SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

• Sponsor: Shire (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01760889
• Collaborator: (none)
• Enrollment: 1
• Locations: 4
• Arms: 3
• Actual Duration (Months): 1.9
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: SPD489 low dose range (40mg, 80mg, and 100mg); Drug: SPD489 high dose range (120mg, 140mg and 160mg); Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 26-week, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 Low Dose Range (40mg, 80mg, 100mg) and High Dose Range (120mg, 140mg, 160mg) as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia
• Actual Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPD489 Low Dose Range	Drug: SPD489 low dose range (40mg, 80mg, and 100mg); Capsule, dose titration, 40 mg capsule once-daily for 1 week; then 80 mg capsule once-daily for 4 weeks; then, 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks; Other Names: lisdexamfetamine dimesylate, LDX, Vyvanse
Experimental: SPD489 High Dose Range	Drug: SPD489 high dose range (120mg, 140mg and 160mg); Capsule, dose titration, 40 mg capsule once-daily for 1 week; then 80 mg capsule once daily for 1 week; then 120 mg capsule once-daily for 1 week, then, 140 mg capsule once-daily for 2 weeks, then 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks; Other Names: lisdexamfetamine dimesylate, LDX, Vyvanse
Placebo Comparator: Placebo	Drug: Placebo; One capsule a day for 26 weeks

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks [Baseline and 26 weeks]

Secondary Outcome Measures

1. Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks [Baseline and 26 weeks]

2. Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks [Baseline and 26 weeks]

3. Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks [Baseline and 26 weeks]

4. Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks [Baseline and 26 weeks]

5. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks [Baseline and 26 weeks]

6. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks [Baseline and 26 weeks]

7. Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks [Baseline and 26 weeks]

8. Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale [Baseline and week 26]

9. Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale [Up to 26 weeks]

10. Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks [Baseline and 26 weeks]

11. Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks [Baseline and 26 weeks]

12. Columbia-Suicide Severity Rating Scale (C-SSRS) [Up to 26 weeks]

13. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks [Baseline and 26 weeks]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• • 18 to 65 years of age

• Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject)

• Fixed home/place of residence and can be reached by telephone

• On a stable dose of antipsychotic medications

• Able to swallow capsules

Exclusion Criteria:

• Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products

• Treated with clozapine in past 30 days

• Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence

• History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions

• Uncontrolled hypertension

• History of thyroid disorder that has not been stabilized on thyroid medication

• Glaucoma

• Pregnant or nursing

• Subject has received an investigational product or participated in a clinical study within 30 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galiz Research	Miami Springs	Florida	United States	33166
2	Psychiatric Care and Research Center	O'Fallon	Missouri	United States	63368
3	St. Charles Psychiatric Associates	Saint Charles	Missouri	United States	63304
4	CRI Lifetree	Philadelphia	Pennsylvania	United States	19139

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: NCT01760889
• Other Study ID Numbers: SPD489-335; 2012-003919-57
• First Posted: Jan 4, 2013
• Last Update Posted: Jun 22, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Schizophrenia; Lisdexamfetamine Dimesylate

Study Results

Participant Flow

Pre-assignment Detail	Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Period Title: Overall Study
STARTED	0	0	0
COMPLETED	0	0	0
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo	Total
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks	Total of all reporting groups
Overall Participants	0	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male
Region of Enrollment () []

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks
Time Frame	Baseline and 26 weeks

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

2. Secondary Outcome

Title	Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks
Time Frame	Baseline and 26 weeks

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

3. Secondary Outcome

Title	Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks
Time Frame	Baseline and 26 weeks

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

4. Secondary Outcome

Title	Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks
Time Frame	Baseline and 26 weeks

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

5. Secondary Outcome

Title	Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks
Time Frame	Baseline and 26 weeks

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

6. Secondary Outcome

Title	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks
Time Frame	Baseline and 26 weeks

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

7. Secondary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks
Time Frame	Baseline and 26 weeks

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

8. Secondary Outcome

Title	Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks
Time Frame	Baseline and 26 weeks

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

9. Secondary Outcome

Title	Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Time Frame	Baseline and week 26

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

10. Secondary Outcome

Title	Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Time Frame	Up to 26 weeks

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

11. Secondary Outcome

Title	Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks
Time Frame	Baseline and 26 weeks

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

12. Secondary Outcome

Title	Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks
Time Frame	Baseline and 26 weeks

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

13. Secondary Outcome

Title	Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame	Up to 26 weeks

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

14. Secondary Outcome

Title	Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks
Time Frame	Baseline and 26 weeks

Outcome Measure Data

Analysis Population Description

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Arm/Group Title	SPD489 Low Dose Range	SPD489 High Dose Range	Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks	SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks	Placebo: One capsule a day for 26 weeks
Measure Participants	0	0	0

Adverse Events

Adverse Event Reporting Description	Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title	SPD489 Low Dose Range		SPD489 High Dose Range		Placebo
Arm/Group Description	SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks		SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks		Placebo: One capsule a day for 26 weeks
All Cause Mortality
	SPD489 Low Dose Range		SPD489 High Dose Range		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	SPD489 Low Dose Range		SPD489 High Dose Range		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	SPD489 Low Dose Range		SPD489 High Dose Range		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

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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.