Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01457339
• Collaborator: (none)
• Enrollment: 31
• Locations: 2
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site: 15.5
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: SPD489 (Lisdexamfetamine dimesylate); Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending, Multiple Oral Doses of SPD489 (Lisdexamfetamine Dimesylate) in Clinically Stable Adults With Schizophrenia
• Actual Study Start Date: Oct 21, 2011
• Actual Primary Completion Date: Jan 20, 2012
• Actual Study Completion Date: Jan 20, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPD489 (Lisdexamfetamine dimesylate)	Drug: SPD489 (Lisdexamfetamine dimesylate); SPD489 administered orally in ascending doses (50mg, 70mg, 100mg, 150mg, 200mg, 250mg). Each of these doses will be administered once daily for 5 days. Total number of days dosed is 30 days.; Other Names: Vyvanse, LDX
Placebo Comparator: Placebo	Drug: Placebo; Placebo Capsule(s) for oral use taken once daily for 30 days

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg [Baseline and day 5]

   Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

2. Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg [Baseline and day 5]

   Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

3. Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg [Baseline and day 5]

   Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

4. Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg [Baseline and day 5]

   Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

5. Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg [Baseline and day 5]

   Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

6. Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg [Baseline and day 5]

   Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

7. Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg [Baseline and day 5]

   Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

8. Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg [Baseline and day 5]

   Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

9. Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg [Baseline and day 5]

   Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

10. Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg [Baseline and day 5]

    Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

11. Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg [Baseline and day 5]

    Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

12. Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg [Baseline and day 5]

    Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

13. Change From Baseline in Pulse Rate at Day 5: 50 mg [Baseline and day 5]

    Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

14. Change From Baseline in Pulse Rate at Day 5: 70 mg [Baseline and day 5]

    Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

15. Change From Baseline in Pulse Rate at Day 5: 100 mg [Baseline and day 5]

    Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

16. Change From Baseline in Pulse Rate at Day 5: 150 mg [Baseline and day 5]

    Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

17. Change From Baseline in Pulse Rate at Day 5: 200 mg [Baseline and day 5]

    Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

18. Change From Baseline in Pulse Rate at Day 5: 250 mg [Baseline and day 5]

    Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Secondary Outcome Measures

1. Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg [Day 5 (12-hour sampling period post-dose)]

   AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

2. Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg [Day 5 (12-hour sampling period post-dose)]

   AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

3. Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg [Day 5 (12-hour sampling period post-dose)]

   AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

4. Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg [Day 5 (12-hour sampling period post-dose)]

   AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

5. Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg [Day 5 (12-hour sampling period post-dose)]

   AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

6. Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg [Day 5 (12-hour sampling period post-dose)]

   AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

7. Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg [Day 5 (12-hour sampling period post-dose)]

   Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

8. Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg [Day 5 (12-hour sampling period post-dose)]

   Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

9. Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg [Day 5 (12-hour sampling period post-dose)]

   Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

10. Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg [Day 5 (12-hour sampling period post-dose)]

    Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

11. Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg [Day 5 (12-hour sampling period post-dose)]

    Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

12. Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg [Day 5 (12-hour sampling period post-dose)]

    Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

13. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg [Baseline and Day 5]

    The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.

14. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg [Baseline and Day 5]

    The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.

15. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg [Baseline and Day 5]

    The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.

16. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg [Baseline and Day 5]

    The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.

17. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg [Baseline and Day 5]

    The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.

18. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg [Baseline and Day 5]

    The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.

19. Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg [Baseline and Day 5]

    The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.

20. Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg [Baseline and Day 5]

    The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.

21. Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg [Baseline and Day 5]

    The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.

22. Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg [Baseline and Day 5]

    The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.

23. Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg [Baseline and Day 5]

    The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.

24. Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg [Baseline and Day 5]

    The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.

25. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg [Baseline and Day 5]

    CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.

26. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg [Baseline and Day 5]

    CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.

27. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg [Baseline and Day 5]

    CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.

28. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg [Baseline and Day 5]

    CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.

29. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg [Baseline and Day 5]

    CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.

30. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg [Baseline and Day 5]

    CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.

31. Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg [Baseline and Day 5]

    SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.

32. Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg [Baseline and Day 5]

    SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.

33. Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg [Baseline and Day 5]

    SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.

34. Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg [Baseline and Day 5]

    SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.

35. Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg [Baseline and Day 5]

    SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.

36. Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg [Baseline and Day 5]

    SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.

37. Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg [Baseline and Day 5]

    BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.

38. Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg [Baseline and Day 5]

    BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.

39. Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg [Baseline and Day 5]

    BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.

40. Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg [Baseline and Day 5]

    BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.

41. Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg [Baseline and Day 5]

    BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.

42. Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg [Baseline and Day 5]

    BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.

43. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

44. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

45. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

46. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

47. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

48. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

49. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

50. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

51. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

52. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

53. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

54. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

55. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

56. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

57. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

58. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

59. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

60. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

61. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

62. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

63. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

64. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

65. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

66. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg [Baseline and Day 5]

    This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Subjects must be diagnosed with schizophrenia, on a stable dose of an antipsychotic and not have any cardiac risk factors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Clinical Trials	Glendale	California	United States	91206
2	Collaborative Neuroscience Network, Inc	Long Beach	California	United States	90806

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT01457339
• Other Study ID Numbers: SPD489-119
• First Posted: Oct 21, 2011
• Last Update Posted: Jun 3, 2021
• Last Verified: May 1, 2021

• Keywords provided by Shire: Schizophrenia
• Additional relevant MeSH terms: Schizophrenia; Lisdexamfetamine Dimesylate

Study Results

Participant Flow

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 30 days	Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
Period Title: Period 1 (50 mg)
STARTED	7	24
COMPLETED	7	24
NOT COMPLETED	0	0
Period Title: Period 1 (50 mg)
STARTED	7	24
COMPLETED	7	24
NOT COMPLETED	0	0
Period Title: Period 1 (50 mg)
STARTED	7	24
COMPLETED	7	23
NOT COMPLETED	0	1
Period Title: Period 1 (50 mg)
STARTED	7	23
COMPLETED	7	23
NOT COMPLETED	0	0
Period Title: Period 1 (50 mg)
STARTED	7	23
COMPLETED	7	22
NOT COMPLETED	0	1
Period Title: Period 1 (50 mg)
STARTED	7	22
COMPLETED	6	21
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(All Doses)	Total
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 30 days	Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).	Total of all reporting groups
Overall Participants	7	24	31
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	24 100%	31 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.6 (4.93)	46.4 (7.86)	47.1 (7.35)
Sex: Female, Male (Count of Participants)
Female	1 14.3%	5 20.8%	6 19.4%
Male	6 85.7%	19 79.2%	25 80.6%
Region of Enrollment (Count of Participants)
United States	7 100%	24 100%	31 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Deviation) [mmHg]	-0.14 (9.543)	8.94 (11.510)

2. Primary Outcome

Title	Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Deviation) [mmHg]	1.43 (12.593)	3.82 (9.258)

3. Primary Outcome

Title	Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Deviation) [mmHg]	0.43 (6.448)	4.96 (9.208)

4. Secondary Outcome

Title	Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg
Description	AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame	Day 5 (12-hour sampling period post-dose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Arm/Group Title	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	24
Mean (Standard Deviation) [ng*hr/ml]	25.6 (12.9)

5. Secondary Outcome

Title	Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg
Description	AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame	Day 5 (12-hour sampling period post-dose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Arm/Group Title	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	24
Mean (Standard Deviation) [ng*hr/ml]	43.7 (27.5)

6. Secondary Outcome

Title	Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg
Description	AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame	Day 5 (12-hour sampling period post-dose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Arm/Group Title	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	23
Mean (Standard Deviation) [ng*hr/ml]	80.5 (37.2)

7. Secondary Outcome

Title	Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg
Description	AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame	Day 5 (12-hour sampling period post-dose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Arm/Group Title	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	22
Mean (Standard Deviation) [ng*hr/ml]	144.9 (43.7)

8. Secondary Outcome

Title	Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg
Description	AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame	Day 5 (12-hour sampling period post-dose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Arm/Group Title	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	21
Mean (Standard Deviation) [ng*hr/ml]	230.2 (81.1)

9. Secondary Outcome

Title	Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg
Description	AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame	Day 5 (12-hour sampling period post-dose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Arm/Group Title	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	21
Mean (Standard Deviation) [ng*hr/ml]	301.5 (105.9)

10. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg
Description	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame	Day 5 (12-hour sampling period post-dose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Arm/Group Title	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	24
Mean (Standard Deviation) [ng/ml]	21.93 (9.96)

11. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg
Description	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame	Day 5 (12-hour sampling period post-dose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Arm/Group Title	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	24
Mean (Standard Deviation) [ng/ml]	35.02 (21.35)

12. Primary Outcome

Title	Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Deviation) [mmHg]	-2.81 (7.358)	6.43 (13.519)

13. Primary Outcome

Title	Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Deviation) [mmHg]	-2.38 (11.546)	5.28 (11.761)

14. Primary Outcome

Title	Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	6	22
Mean (Standard Deviation) [mmHg]	-0.28 (13.442)	7.36 (15.569)

15. Primary Outcome

Title	Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Deviation) [mmHg]	2.86 (11.547)	5.22 (8.364)

16. Primary Outcome

Title	Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Deviation) [mmHg]	2.38 (10.557)	2.14 (6.468)

17. Primary Outcome

Title	Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Deviation) [mmHg]	2.14 (7.796)	4.55 (7.641)

18. Primary Outcome

Title	Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Deviation) [mmHg]	2.67 (10.846)	2.43 (10.672)

19. Primary Outcome

Title	Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Deviation) [mmHg]	2.76 (14.442)	3.77 (8.041)

20. Primary Outcome

Title	Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	6	22
Mean (Standard Deviation) [mmHg]	3.67 (8.618)	3.79 (10.106)

21. Primary Outcome

Title	Change From Baseline in Pulse Rate at Day 5: 50 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Deviation) [beats/min]	2.62 (9.534)	3.78 (11.116)

22. Primary Outcome

Title	Change From Baseline in Pulse Rate at Day 5: 70 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Deviation) [beats/min]	-0.95 (9.821)	5.07 (9.500)

23. Primary Outcome

Title	Change From Baseline in Pulse Rate at Day 5: 100 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Deviation) [beats/min]	0.19 (10.306)	5.72 (12.578)

24. Primary Outcome

Title	Change From Baseline in Pulse Rate at Day 5: 150 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Deviation) [beats/min]	-1.05 (8.125)	6.41 (13.782)

25. Primary Outcome

Title	Change From Baseline in Pulse Rate at Day 5: 200 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Deviation) [beats/min]	2.38 (10.058)	8.88 (12.206)

26. Primary Outcome

Title	Change From Baseline in Pulse Rate at Day 5: 250 mg
Description	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame	Baseline and day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	6	22
Mean (Standard Deviation) [beats/min]	2.06 (9.760)	12.39 (12.666)

27. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg
Description	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame	Day 5 (12-hour sampling period post-dose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Arm/Group Title	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	23
Mean (Standard Deviation) [ng/ml]	50.6 (18.9)

28. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg
Description	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame	Day 5 (12-hour sampling period post-dose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Arm/Group Title	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	22
Mean (Standard Deviation) [ng/ml]	90.34 (30.45)

29. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg
Description	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame	Day 5 (12-hour sampling period post-dose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Arm/Group Title	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	21
Mean (Standard Deviation) [ng/ml]	133.3 (63.17)

30. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg
Description	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame	Day 5 (12-hour sampling period post-dose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Arm/Group Title	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	21
Mean (Standard Deviation) [ng/ml]	181.53 (72.82)

31. Secondary Outcome

Title	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg
Description	The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [units on a scale]	0.6 (2.22)	-1.9 (1.10)

32. Secondary Outcome

Title	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg
Description	The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [units on a scale]	-2.1 (1.81)	-2.9 (1.50)

33. Secondary Outcome

Title	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg
Description	The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [units on a scale]	-3.6 (1.43)	-3.9 (1.68)

34. Secondary Outcome

Title	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg
Description	The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [units on a scale]	-2.1 (1.40)	-4.7 (1.44)

35. Secondary Outcome

Title	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg
Description	The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	22
Mean (Standard Error) [units on a scale]	-2.3 (2.01)	-4.6 (1.81)

36. Secondary Outcome

Title	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg
Description	The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	6	22
Mean (Standard Error) [units on a scale]	-2.3 (2.03)	-2.4 (2.01)

37. Secondary Outcome

Title	Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg
Description	The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [units on a scale]	-1.4 (1.54)	-1.7 (1.09)

38. Secondary Outcome

Title	Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg
Description	The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [units on a scale]	-3.0 (2.85)	-3.1 (1.15)

39. Secondary Outcome

Title	Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg
Description	The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [units on a scale]	-7.0 (3.07)	-2.6 (1.27)

40. Secondary Outcome

Title	Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg
Description	The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [units on a scale]	-4.0 (3.24)	-3.0 (1.17)

41. Secondary Outcome

Title	Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg
Description	The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	22
Mean (Standard Error) [units on a scale]	1.3 (3.75)	-2.6 (1.11)

42. Secondary Outcome

Title	Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg
Description	The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	6	22
Mean (Standard Error) [units on a scale]	-4.2 (2.15)	-3.3 (1.47)

43. Secondary Outcome

Title	Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg
Description	CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [units on a scale]	0.0 (0.38)	-0.3 (0.35)

44. Secondary Outcome

Title	Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg
Description	CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [units on a scale]	-0.4 (0.30)	-0.7 (0.28)

45. Secondary Outcome

Title	Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg
Description	CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [units on a scale]	-0.4 (0.30)	-0.9 (0.34)

46. Secondary Outcome

Title	Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg
Description	CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [units on a scale]	-0.7 (0.47)	-1.0 (0.35)

47. Secondary Outcome

Title	Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg
Description	CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	22
Mean (Standard Error) [units on a scale]	-0.4 (0.30)	-0.6 (0.28)

48. Secondary Outcome

Title	Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg
Description	CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	6	22
Mean (Standard Error) [units on a scale]	-0.2 (0.40)	-0.3 (0.48)

49. Secondary Outcome

Title	Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg
Description	SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [units on a scale]	-0.4 (0.30)	0.0 (0.18)

50. Secondary Outcome

Title	Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg
Description	SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [units on a scale]	-0.6 (0.43)	-0.1 (0.18)

51. Secondary Outcome

Title	Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg
Description	SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [units on a scale]	-0.4 (0.48)	0.0 (0.21)

52. Secondary Outcome

Title	Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg
Description	SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [units on a scale]	-0.3 (0.29)	0.1 (0.19)

53. Secondary Outcome

Title	Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg
Description	SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	6	22
Mean (Standard Error) [units on a scale]	0.0 (0.52)	0.0 (0.20)

54. Secondary Outcome

Title	Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg
Description	SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	6	22
Mean (Standard Error) [units on a scale]	0.2 (0.31)	0.0 (0.21)

55. Secondary Outcome

Title	Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg
Description	BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [units on a scale]	0.0 (0.00)	0.0 (0.00)

56. Secondary Outcome

Title	Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg
Description	BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [units on a scale]	0.0 (0.00)	0.0 (0.00)

57. Secondary Outcome

Title	Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg
Description	BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [units on a scale]	0.0 (0.00)	0.0 (0.00)

58. Secondary Outcome

Title	Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg
Description	BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [units on a scale]	0.0 (0.00)	0.0 (0.00)

59. Secondary Outcome

Title	Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg
Description	BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	22
Mean (Standard Error) [units on a scale]	0.0 (0.00)	0.2 (0.11)

60. Secondary Outcome

Title	Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg
Description	BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	6	22
Mean (Standard Error) [units on a scale]	0.0 (0.00)	0.0 (0.05)

61. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [Number of Errors]	-0.9 (8.02)	-8.2 (5.79)

62. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [Number of Errors]	8.7 (10.77)	-7.3 (6.45)

63. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [Number of Errors]	0.9 (9.55)	-15.7 (6.57)

64. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [Number of Errors]	21.1 (28.75)	-11.3 (6.26)

65. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	22
Mean (Standard Error) [Number of Errors]	-10.3 (6.30)	-16.5 (6.65)

66. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	6	22
Mean (Standard Error) [Number of Errors]	-5.0 (8.74)	-13.2 (5.25)

67. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [Log10 milliseconds]	0.0 (0.0389)	-0.034 (0.0223)

68. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [Log10 milliseconds]	0.017 (0.0411)	-0.015 (0.0195)

69. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [Log10 milliseconds]	0.014 (0.0492)	-0.047 (0.0246)

70. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [Log10 milliseconds]	0.037 (0.0373)	-0.039 (0.0180)

71. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	22
Mean (Standard Error) [Log10 milliseconds]	-0.025 (0.0395)	-0.049 (0.0178)

72. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	6	22
Mean (Standard Error) [Log10 milliseconds]	-0.034 (0.0581)	-0.048 (0.0147)

73. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [Log10 milliseconds]	0.028 (0.0304)	0.001 (0.0141)

74. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [Log10 milliseconds]	0.015 (0.0273)	0.006 (0.0113)

75. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [Log10 milliseconds]	0.011 (0.0348)	0.001 (0.0171)

76. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [Log10 milliseconds]	0.036 (0.0419)	-0.010 (0.0172)

77. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	22
Mean (Standard Error) [Log10 milliseconds]	0.044 (0.0397)	-0.014 (0.0157)

78. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	6	22
Mean (Standard Error) [Log10 milliseconds]	0.005 (0.0531)	-0.007 (0.0144)

79. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 50 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [Arcsine proportion correct]	0.025 (0.0234)	0.005 (0.0179)

80. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 70 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	24
Mean (Standard Error) [Arcsine proportion correct]	0.015 (0.0322)	0.021 (0.0189)

81. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 100 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [Arcsine proportion correct]	0.012 (0.0373)	0.012 (0.0197)

82. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Measure Participants	7	23
Mean (Standard Error) [Arcsine proportion correct]	0.026 (0.0415)	0.042 (0.0222)

83. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 200 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	7	22
Mean (Standard Error) [Arcsine proportion correct]	-0.020 (0.0394)	0.046 (0.0219)

84. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg
Description	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame	Baseline and Day 5

Outcome Measure Data

Analysis Population Description

Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm/Group Title	Placebo	SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 5 days	Oral 250 mg dose of SPD489 administered once daily for 5 days.
Measure Participants	6	22
Mean (Standard Error) [Arcsine proportion correct]	0.018 (0.0432)	0.022 (0.0250)

Adverse Events

Arm/Group Title	Placebo		SPD489 (Lisdexamfetamine Dimesylate)(50 mg)		SPD489 (Lisdexamfetamine Dimesylate)(70 mg)		SPD489 (Lisdexamfetamine Dimesylate)(100 mg)		SPD489 (Lisdexamfetamine Dimesylate)(150 mg)		SPD489 (Lisdexamfetamine Dimesylate)(200 mg)		SPD489 (Lisdexamfetamine Dimesylate)(250 mg)		SPD489 (Lisdexamfetamine Dimesylate)(All Doses)
Arm/Group Description	Placebo Capsule(s) for oral use taken once daily for 30 days		Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).		Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).		Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).		Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).		Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).		Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).		Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
All Cause Mortality
	Placebo		SPD489 (Lisdexamfetamine Dimesylate)(50 mg)		SPD489 (Lisdexamfetamine Dimesylate)(70 mg)		SPD489 (Lisdexamfetamine Dimesylate)(100 mg)		SPD489 (Lisdexamfetamine Dimesylate)(150 mg)		SPD489 (Lisdexamfetamine Dimesylate)(200 mg)		SPD489 (Lisdexamfetamine Dimesylate)(250 mg)		SPD489 (Lisdexamfetamine Dimesylate)(All Doses)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		SPD489 (Lisdexamfetamine Dimesylate)(50 mg)		SPD489 (Lisdexamfetamine Dimesylate)(70 mg)		SPD489 (Lisdexamfetamine Dimesylate)(100 mg)		SPD489 (Lisdexamfetamine Dimesylate)(150 mg)		SPD489 (Lisdexamfetamine Dimesylate)(200 mg)		SPD489 (Lisdexamfetamine Dimesylate)(250 mg)		SPD489 (Lisdexamfetamine Dimesylate)(All Doses)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/23 (0%)		0/23 (0%)		0/22 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		SPD489 (Lisdexamfetamine Dimesylate)(50 mg)		SPD489 (Lisdexamfetamine Dimesylate)(70 mg)		SPD489 (Lisdexamfetamine Dimesylate)(100 mg)		SPD489 (Lisdexamfetamine Dimesylate)(150 mg)		SPD489 (Lisdexamfetamine Dimesylate)(200 mg)		SPD489 (Lisdexamfetamine Dimesylate)(250 mg)		SPD489 (Lisdexamfetamine Dimesylate)(All Doses)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/7 (57.1%)		15/24 (62.5%)		7/24 (29.2%)		8/24 (33.3%)		12/23 (52.2%)		10/23 (43.5%)		12/22 (54.5%)		23/24 (95.8%)
Cardiac disorders
Tachycardia	2/7 (28.6%)	2	3/24 (12.5%)	3	1/24 (4.2%)	1	1/24 (4.2%)	1	2/23 (8.7%)	2	0/23 (0%)	0	1/22 (4.5%)	1	6/24 (25%)	8
Eye disorders
Vision blurred	0/7 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	1/23 (4.3%)	1	1/22 (4.5%)	1	2/24 (8.3%)	2
Gastrointestinal disorders
Constipation	0/7 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	2	0/24 (0%)	0	0/23 (0%)	0	3/23 (13%)	3	0/22 (0%)	0	5/24 (20.8%)	5
Nausea	1/7 (14.3%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	3/23 (13%)	3	2/23 (8.7%)	2	2/22 (9.1%)	2	4/24 (16.7%)	7
Diarrhea	0/7 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	1/24 (4.2%)	1	0/23 (0%)	0	0/23 (0%)	0	0/22 (0%)	0	2/24 (8.3%)	2
Dry Mouth	0/7 (0%)	0	1/24 (4.2%)	1	1/24 (4.2%)	1	1/24 (4.2%)	1	0/23 (0%)	0	1/23 (4.3%)	1	0/22 (0%)	0	3/24 (12.5%)	4
Dyspepsia	0/7 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	0/23 (0%)	0	0/23 (0%)	0	1/22 (4.5%)	1	2/24 (8.3%)	2
Vomiting	1/7 (14.3%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	1/22 (4.5%)	1	1/24 (4.2%)	1
Infections and infestations
Folliculitis	0/7 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	2/22 (9.1%)	2	2/24 (8.3%)	2
Investigations
Blood Pressure Increased	0/7 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	1/22 (4.5%)	1	2/24 (8.3%)	2
Metabolism and nutrition disorders
Decreased appetite	0/7 (0%)	0	4/24 (16.7%)	4	0/24 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/22 (0%)	0	4/24 (16.7%)	4
Increased Appetite	1/7 (14.3%)	1	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	1/22 (4.5%)	1	2/24 (8.3%)	2
Musculoskeletal and connective tissue disorders
Muscle Spasms	1/7 (14.3%)	1	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/22 (0%)	0	1/24 (4.2%)	1
Musculoskeletal Pain	1/7 (14.3%)	2	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/22 (0%)	0	0/24 (0%)	0
Nervous system disorders
Headache	1/7 (14.3%)	1	1/24 (4.2%)	1	0/24 (0%)	0	1/24 (4.2%)	1	4/23 (17.4%)	5	1/23 (4.3%)	1	4/22 (18.2%)	5	4/24 (16.7%)	13
Tremor	1/7 (14.3%)	1	1/24 (4.2%)	1	1/24 (4.2%)	1	1/24 (4.2%)	1	2/23 (8.7%)	2	1/23 (4.3%)	1	1/22 (4.5%)	1	5/24 (20.8%)	7
Akathisia	0/7 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/23 (4.3%)	1	1/23 (4.3%)	1	0/22 (0%)	0	2/24 (8.3%)	2
Syncope Vasovagal	1/7 (14.3%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	0/22 (0%)	0	0/24 (0%)	0
Psychiatric disorders
Insomnia	0/7 (0%)	0	3/24 (12.5%)	3	1/24 (4.2%)	1	1/24 (4.2%)	1	2/23 (8.7%)	2	0/23 (0%)	0	1/22 (4.5%)	1	5/24 (20.8%)	8
Anxiety	0/7 (0%)	0	2/24 (8.3%)	2	1/24 (4.2%)	1	0/24 (0%)	0	0/23 (0%)	0	0/23 (0%)	0	2/22 (9.1%)	2	4/24 (16.7%)	5
Psychotic Disorder	0/7 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/23 (4.3%)	1	1/23 (4.3%)	1	0/22 (0%)	0	2/24 (8.3%)	2
Reproductive system and breast disorders
Dysmenorrhea	0/7 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	2	0/23 (0%)	0	0/23 (0%)	0	0/22 (0%)	0	2/24 (8.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.