A Study of Safety and Tolerability in Subjects With Schizophrenia

• Sponsor: Denovo Biopharma LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01354353
• Collaborator: (none)
• Enrollment: 75
• Locations: 2
• Arms: 7
• Duration (Months): 10
• Patients Per Site: 37.5
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated therapeutic exposure under clinical investigation. In the event of poor tolerability in Part A of this study Part B may be conducted to explore higher doses using titration. Participants in both Parts A and B will participate in a 9 day wash-out period of current medication (Study Days 1-9); participants coming into the study on aripiprazole will remain on their current therapy throughout.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: LY2140023; Drug: Aripiprazole	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Safety and Tolerability of Multiple Ascending Doses of LY2140023 in Subjects With Schizophrenia
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aripiprazole Part A: Continue current prescribed dosing regimen -- Study Day 1 to discharge (Study Day 21). Part B: Continue current prescribed dosing regimen (≤ 30 milligrams [mg]/day ) -- Study Day 1 to discharge (Study Day 23, 25 or 28 based on adaptive design)	Drug: Aripiprazole; Administered orally
Experimental: Part A: 160 mg LY2140023 Administered orally, twice daily (BID) for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16)	Drug: LY2140023; Administered orally
Experimental: Part A: 240 mg LY2140023 Administered orally BID for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16)	Drug: LY2140023; Administered orally
Experimental: Part A: 320 mg LY2140023 Administered orally BID for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16)	Drug: LY2140023; Administered orally
Experimental: Part A: 400 mg LY2140023 Administered orally BID for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16)	Drug: LY2140023; Administered orally
Experimental: Part A: 480 mg LY2140023 Administered orally BID for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16)	Drug: LY2140023; Administered orally
Experimental: Part B: LY2140023 If doses up to or equal to 400 mg BID are not tolerated, Part B of the study may be started. The dose of LY2140023 will be titrated in the same participant from highest dose that was tolerated in Part A, with the intention to reach a dose of 480 mg LY2140023.	Drug: LY2140023; Administered orally

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) [Baseline up to Day 21 for Part A]

   Participants with at least 1 postdose (Day 10 through the end of study visit [Day 21]) treatment emergent adverse event (TEAE) were counted by dose cohort. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Secondary Outcome Measures

1. Part A: Pharmacokinetics, Maximum Concentration (Cmax) [Pre-dose and post-dose on Day 10 and Day 16]

2. Part B: Pharmacokinetics, Maximum Concentration (Cmax) [Pre-dose and post-dose on Days 12, 15, 18, 21, and 24]

   Part B of this study was not conducted; therefore, no data are available for analysis.

3. Part A: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC) [Pre-dose and post-dose on Day 10 and Day 16]

   The Day 10 parameter is area under the concentration versus time curve from time zero to infinity (AUC[0-inf]) post-single dose of LY2140023. The Day 16 parameter is area under the concentration versus time curve in a dosing interval (AUC[0-tau]) post-repeated daily doses of LY2140023.

4. Part B: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC) [Pre-dose and post-dose on Days 12, 15, 18, 21, and 24]

   Part B of this study was not conducted; therefore, no data are available for analysis.

5. Percentage of Participants With Increased Severity From Baseline to Day 17 in Clinical Global Impression- Severity Scale (CGI-S) [Baseline through Day 17 for Part A]

   Clinical Global Impression- Severity Scale (CGI-S) measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The classification includes 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, and 7 = Among the most extremely ill patients. Increases or higher scores indicate increasing severity. Only incidences of selected shifts of increasing severity (an increase in numbers on a scale) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.

6. Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Brief Psychiatric Rating Scale (BPRS) [Baseline through Day 17 for Part A]

   Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a participant's general psychopathological symptoms. Item scores ranged from 0 (not assessed) to 7 (extremely severe). Total Scores ranged from 0 to 126. Increases or higher scores indicate a worsening of symptoms. Only incidences of selected shifts of worsening symptoms (an increase in numbers on a scale within the 18-symptom construct) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.

7. Percentage of Participants With Worsening Severity From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS) [Baseline through Day 17 for Part A]

   The Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Increases or higher scores indicate a worsening of symptoms. The classification includes 0 = None, 1 = Minimal, may be extreme normal, 2 = Mild, 3 = Moderate, and 4 - Severe. Only incidences of selected shifts of worsening severity (an increase in numbers on a scale within the 10-item construct) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.

8. Percentage of Participants With Increasing Impairment From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Simpson-Angus Scale (SAS) [Baseline through Day 17 for Part A]

   Simpson-Angus Scale (SAS) is used to measure Parkinsonian-type symptoms in participants exposed to antipsychotics. The scale consists of 10 items each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The total score is obtained by adding the items. Increases or higher scores indicate a worsening of impairment. Only incidences of selected shifts of increasing impairment (an increase in numbers on a scale within the 10-symptom construct) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.

9. Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Scale (BAS) [Baseline through Day 17 for Part A]

   Barnes Akathisia Rating Scale (BAS) evaluates observable, restless movements of drug-induced akathisia associated with use of antipsychotic medications, includes objective (1-item) and subjective component (2-items, awareness of movement and distress related to movement) plus Global Clinical Assessment for overall disorder. Components were rated on a 4-point scale for the objective (0 = normal and 3 = constantly restless) and subjective items ((0 = absence of inner restlessness and 3 = awareness of intense compulsion to move for one item; and 0 = no distress and 3 = severe for the other item) and scored on a 6-point scale for the Global Clinical Assessment (0 = absent and 5 = severe). Increases or higher scores indicate a worsening of symptoms. Only incidences of selected shifts of worsening symptoms (an increase in numbers on a scale within the components) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Have a diagnosis of schizophrenic disorder

• Female participants who test negative for pregnancy at screening and agree to use a reliable method of birth control for the duration of the study and for at least 3 months after the last LY2140023 dose or are postmenopausal

• Not have been hospitalized for psychiatric illness for at least 12 weeks prior to Day 1 of washout period and have a Clinical Global Impression -Severity (CGI-S) scale score of <4

• Be willing and able as determined by the investigator to be hospitalized from the beginning of the washout period to the end of the study

• In the opinion of the investigator, the participant can be washed out of their Standard of Care (SOC) therapy (other than aripiprazole for the aripiprazole participants) for the duration of the study without detrimental effect to the participant's mental health (CGI-S <4 after completion of the washout period)

• Be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures

• Be able to understand the nature of the study and have given their own informed consent

• Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

• Have venous access sufficient to allow blood sampling

• Clinically acceptable sitting blood pressure and pulse rate, as determined by the investigator

Participants on Aripiprazole prior to study entry must:

• On a stable dose of aripiprazole within the approved range in product labeling (less than or equal to 30 milligrams [mg]/day) for at least 60 days prior to Day 1 and with no anticipation of changes to dose, regimen (except as required for this study) or treatment within the next 1 month

Exclusion Criteria:

• Currently enrolled in, or discontinued within the 30 days prior to screening from, a clinical trial involving an investigational drug or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

• Have known allergies to LY2140023, LY404039, aripiprazole, or related compounds

• Participants with moderate to severe renal impairment as defined by creatinine clearance (CrCl) <60 milliliters (mL)/minute (min)

• Have previously completed this study or have discontinued from any study investigating LY2140023 after having received at least 1 dose of LY2140023

• Participants for whom treatment with LY2140023 or aripiprazole as specified in this protocol, is relatively or absolutely clinically contraindicated

• Participants who have received treatment with clozapine

• Participants who have a diagnosis of schizophrenia who are taking either thioridazine or thiothixene

• Participants receiving treatment with depot antipsychotic medication within 12 weeks, prior to screening

• Participants who are taking any of medications that are specifically excluded

• Participants who have answered 'yes' to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the Columbia suicide severity rating scale (C-SSRS), or answer "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the "Suicidal Behavior" portion of the C-SSRS; and the ideation or behavior occurred within the past 3 months

• Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (Text Revision) (DSM-IV-TR) diagnosis of substance dependence or substance abuse (except nicotine and caffeine) within the 6 months prior to admission

• Diagnosis of substance-induced psychosis by DSM-IV-TR criteria within 7 days of admission (or at any time during the dosing period)

• Have a history of one or more seizures except for either of the following 2 situations: a single simple febrile seizure between ages 6 months and 5 years or a single seizure with an identifiable etiology, which has been completely resolved

• Have a screening electroencephalogram (EEG) with paroxysmal (epileptiform) activity, for example, one that demonstrates 3 or more focal sharp or spike waves, any sharp and slow wave complex, or any epileptiform discharge that is rhythmic, sustained, or generalized, or as locally defined

• Participants who have had electroconvulsive therapy (ECT) within 3 months of observation period or who are expected to have ECT at any time during the live phase of this study

• A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders

• Participant with untreated hyperthyroidism or hypothyroidism needing a thyroid hormone supplement who have not been on a stable dose of medication for at least 2 months prior to screening

• Have leukopenia or history of leukopenia during the participant's lifetime

• Participants with alanine aminotransferase (ALT/SGPT) or aspartate aminotransferase (AST/SGOT) values >2 times the upper limit of normal (ULN) of the performing laboratory, or total bilirubin values >1.5 times the ULN of the performing laboratory at screening

• Participants with corrected QT interval (Bazett's); QTcB >450 milliseconds (msec) (male) or >470 msec (female) at admission

• Have acute, serious or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (hemoglobin A1c [HgbA1c] >8%), severe hypertriglyceridemia (fasting triglycerides greater than or equal to 500 milligrams/deciliter (mg/dL) or 5.65 micromoles/liter [umol/L]), hepatic insufficiency (specifically any degree of jaundice), recent cerebrovascular accidents, seizure disorders, serious acute systemic infection or immunology disease, unstable cardiovascular disorders (including ischemic heart disease), renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases

• Prolactin level of >200 nanograms/milliliter (ng/mL) (200 micrograms/liter [ug/L], or 4228 milli international units/liter [mIU/L]) at screening with the exception of participants treated with risperidone. Participants treated with risperidone are excluded if the prolactin level is >300 ng/mL (300 ug/L, or 6342 mIU/L) at screening

• Participants with known medical history of Human Immunodeficiency Virus positive (HIV+) status

• Test positive for (1) Hepatitis C virus antibody or (2) Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody. Participants with positive Hepatitis B core antibody test and negative HBsAg may be included in the study if ALT/SGPT and AST/SGOT levels are less than 2 times the ULN and total bilirubin does not exceed the ULN of the central laboratory

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Garden Grove	California	United States	92845
2	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Glendale	California	United States	91206

Sponsors and Collaborators

• Denovo Biopharma LLC

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Denovo Biopharma LLC
• ClinicalTrials.gov Identifier: NCT01354353
• Other Study ID Numbers: 13565; H8Y-MC-HBDB
• First Posted: May 16, 2011
• Last Update Posted: Sep 14, 2021
• Last Verified: Aug 1, 2012

• Additional relevant MeSH terms: Schizophrenia; Aripiprazole

Study Results

Participant Flow

Pre-assignment Detail	This was a 2-part study. The lead-in period was from Days 1 to 9, the test dosing (treatment) period was from Days 10 to 16, and the follow-up period was from Days 17 to 21. Dose escalation in Part A was completed. Part B (dose titration) was optional and not initiated because the objective of the study was met in Part A.

Arm/Group Title	Aripiprazole	160 mg LY2140023	240 mg LY2140023	320 mg LY2140023	400 mg LY2140023	480 mg LY2140023
Arm/Group Description	Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge).	160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
Period Title: Overall Study
STARTED	16	12	11	12	12	12
Received at Least One Dose of Study Drug	16	11	10	11	11	11
COMPLETED	13	11	9	7	11	6
NOT COMPLETED	3	1	2	5	1	6

Baseline Characteristics

Arm/Group Title	Aripiprazole	160 mg LY2140023	240 mg LY2140023	320 mg LY2140023	400 mg LY2140023	480 mg LY2140023	Total
Arm/Group Description	Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge).	160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. (Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)	240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	Total of all reporting groups
Overall Participants	16	12	11	12	12	12	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41 (10)	50 (7)	49 (8)	45 (10)	42 (13)	46 (10)	45 (10)
Sex: Female, Male (Count of Participants)
Female	7 43.8%	3 25%	2 18.2%	2 16.7%	1 8.3%	3 25%	18 24%
Male	9 56.3%	9 75%	9 81.8%	10 83.3%	11 91.7%	9 75%	57 76%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 6.3%	1 8.3%	1 9.1%	0 0%	2 16.7%	0 0%	5 6.7%
Not Hispanic or Latino	15 93.8%	11 91.7%	10 90.9%	12 100%	10 83.3%	12 100%	70 93.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 6.3%	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.3%
Asian	2 12.5%	0 0%	0 0%	0 0%	0 0%	0 0%	2 2.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	10 62.5%	9 75%	9 81.8%	8 66.7%	8 66.7%	8 66.7%	52 69.3%
White	3 18.8%	2 16.7%	2 18.2%	4 33.3%	4 33.3%	4 33.3%	19 25.3%
More than one race	0 0%	1 8.3%	0 0%	0 0%	0 0%	0 0%	1 1.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	16 100%	12 100%	11 100%	12 100%	12 100%	12 100%	75 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests)
Description	Participants with at least 1 postdose (Day 10 through the end of study visit [Day 21]) treatment emergent adverse event (TEAE) were counted by dose cohort. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame	Baseline up to Day 21 for Part A

Outcome Measure Data

Analysis Population Description

Participants who were assigned to treatment and were either dosed or discontinued prior to dosing.

Arm/Group Title	Aripiprazole	160 mg LY2140023	240 mg LY2140023	320 mg LY2140023	400 mg LY2140023	480 mg LY2140023
Arm/Group Description	Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge).	160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. (Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)	240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
Measure Participants	16	12	11	12	12	12
Days 10-16	5 31.3%	6 50%	9 81.8%	11 91.7%	11 91.7%	11 91.7%
Follow-up (Days 17-20)	4 25%	2 16.7%	2 18.2%	2 16.7%	0 0%	2 16.7%
End of Study (Day 21)	1 6.3%	1 8.3%	1 9.1%	1 8.3%	0 0%	1 8.3%

2. Secondary Outcome

Title	Part A: Pharmacokinetics, Maximum Concentration (Cmax)
Time Frame	Pre-dose and post-dose on Day 10 and Day 16

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2140023 with evaluable Cmax data.

Arm/Group Title	160 mg LY2140023	240 mg LY2140023	320 mg LY2140023	400 mg LY2140023	480 mg LY2140023
Arm/Group Description	160 milligrams (mg) LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. Not included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.	240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
Measure Participants	6	11	12	12	12
Day 10 (single dose) (n=5, 7, 9, 9, 6)	496 (65)	1170 (44)	1410 (36)	1830 (23)	2630 (13)
Day 16 (multiple doses) (n=4, 9, 7, 11, 4)	799 (29)	1090 (36)	1510 (38)	1760 (30)	1810 (32)

3. Secondary Outcome

Title	Part B: Pharmacokinetics, Maximum Concentration (Cmax)
Description	Part B of this study was not conducted; therefore, no data are available for analysis.
Time Frame	Pre-dose and post-dose on Days 12, 15, 18, 21, and 24

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed.

Arm/Group Title	160 mg LY2140023	240 mg LY2140023	320 mg LY2140023	400 mg LY2140023	480 mg LY2140023
Arm/Group Description	160 milligrams (mg) LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
Measure Participants	0	0	0	0	0

4. Secondary Outcome

Title	Part A: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC)
Description	The Day 10 parameter is area under the concentration versus time curve from time zero to infinity (AUC[0-inf]) post-single dose of LY2140023. The Day 16 parameter is area under the concentration versus time curve in a dosing interval (AUC[0-tau]) post-repeated daily doses of LY2140023.
Time Frame	Pre-dose and post-dose on Day 10 and Day 16

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2140023 with evaluable AUC data.

Arm/Group Title	160 mg LY2140023	240 mg LY2140023	320 mg LY2140023	400 mg LY2140023	480 mg LY2140023
Arm/Group Description	160 milligrams (mg) administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. Not included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.	240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
Measure Participants	6	11	12	12	12
Day 10 (single dose) (n=5, 7, 9, 9, 6)	2800 (46)	6290 (50)	8100 (37)	10600 (23)	14700 (11)
Day 16 (multiple doses) (n=4, 9, 7, 11, 4)	4370 (21)	6220 (32)	7930 (39)	9890 (28)	10100 (31)

5. Secondary Outcome

Title	Part B: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC)
Description	Part B of this study was not conducted; therefore, no data are available for analysis.
Time Frame	Pre-dose and post-dose on Days 12, 15, 18, 21, and 24

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed.

Arm/Group Title	160 mg LY2140023	240 mg LY2140023	320 mg LY2140023	400 mg LY2140023	480 mg LY2140023
Arm/Group Description	160 milligrams (mg) LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
Measure Participants	0	0	0	0	0

6. Secondary Outcome

Title	Percentage of Participants With Increased Severity From Baseline to Day 17 in Clinical Global Impression- Severity Scale (CGI-S)
Description	Clinical Global Impression- Severity Scale (CGI-S) measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The classification includes 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, and 7 = Among the most extremely ill patients. Increases or higher scores indicate increasing severity. Only incidences of selected shifts of increasing severity (an increase in numbers on a scale) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.
Time Frame	Baseline through Day 17 for Part A

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Clinical Global Impression- Severity Scale data.

Arm/Group Title	Aripiprazole	160 mg LY2140023	240 mg LY2140023	320 mg LY2140023	400 mg LY2140023	480 mg LY2140023
Arm/Group Description	Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge).	160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. (Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)	240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
Measure Participants	16	11	10	11	11	11
Shift From Borderline to Mild	0 0%	0 0%	0 0%	9.1 75.8%	0 0%	0 0%
Shift from Mild to Moderate	6.3 39.4%	9.1 75.8%	20.0 181.8%	0 0%	18.2 151.7%	9.1 75.8%

7. Secondary Outcome

Title	Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Brief Psychiatric Rating Scale (BPRS)
Description	Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a participant's general psychopathological symptoms. Item scores ranged from 0 (not assessed) to 7 (extremely severe). Total Scores ranged from 0 to 126. Increases or higher scores indicate a worsening of symptoms. Only incidences of selected shifts of worsening symptoms (an increase in numbers on a scale within the 18-symptom construct) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.
Time Frame	Baseline through Day 17 for Part A

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Brief Psychiatric Rating Scale data.

Arm/Group Title	Aripiprazole	160 mg LY2140023	240 mg LY2140023	320 mg LY2140023	400 mg LY2140023	480 mg LY2140023
Arm/Group Description	Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge).	160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. (Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)	240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
Measure Participants	16	11	10	11	11	11
Mild to moderately severe - Hallucinatory behavior	12.5 78.1%	0 0%	0 0%	0 0%	0 0%	0 0%
Mild to moderately severe - Anxiety	0 0%	0 0%	10.0 90.9%	0 0%	0 0%	0 0%
Very mild to moderate - Unusual thought content	6.3 39.4%	0 0%	0 0%	0 0%	9.1 75.8%	0 0%
Very mild to moderate - Excitement	0 0%	0 0%	10.0 90.9%	0 0%	0 0%	0 0%
Very mild to moderate - Conceptual disorganization	0 0%	0 0%	0 0%	0 0%	9.1 75.8%	0 0%

8. Secondary Outcome

Title	Percentage of Participants With Worsening Severity From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)
Description	The Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Increases or higher scores indicate a worsening of symptoms. The classification includes 0 = None, 1 = Minimal, may be extreme normal, 2 = Mild, 3 = Moderate, and 4 - Severe. Only incidences of selected shifts of worsening severity (an increase in numbers on a scale within the 10-item construct) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.
Time Frame	Baseline through Day 17 for Part A

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Abnormal Involuntary Movement Scale data.

Arm/Group Title	Aripiprazole	160 mg LY2140023	240 mg LY2140023	320 mg LY2140023	400 mg LY2140023	480 mg LY2140023
Arm/Group Description	Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge).	160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. (Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)	240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
Measure Participants	16	11	10	11	11	11
Normal to Minimal - Jaw	0 0%	0 0%	0 0%	9.1 75.8%	0 0%	0 0%
Normal to Minimal - Muscles of facial expression	0 0%	0 0%	0 0%	0 0%	9.1 75.8%	0 0%

9. Secondary Outcome

Title	Percentage of Participants With Increasing Impairment From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Simpson-Angus Scale (SAS)
Description	Simpson-Angus Scale (SAS) is used to measure Parkinsonian-type symptoms in participants exposed to antipsychotics. The scale consists of 10 items each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The total score is obtained by adding the items. Increases or higher scores indicate a worsening of impairment. Only incidences of selected shifts of increasing impairment (an increase in numbers on a scale within the 10-symptom construct) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.
Time Frame	Baseline through Day 17 for Part A

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Simpson-Angus Scale data.

Arm/Group Title	Aripiprazole	160 mg LY2140023	240 mg LY2140023	320 mg LY2140023	400 mg LY2140023	480 mg LY2140023
Arm/Group Description	Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge).	160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. (Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)	240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
Measure Participants	16	11	10	11	11	11
Normal to Slight - Gait	6.3 39.4%	0 0%	0 0%	0 0%	0 0%	0 0%
Normal to Slight - Head dropping	6.3 39.4%	0 0%	0 0%	0 0%	0 0%	0 0%
Normal to Slight - Tremor	12.5 78.1%	0 0%	10.0 90.9%	9.1 75.8%	0 0%	9.1 75.8%
Normal to Slight - Salivation	6.3 39.4%	0 0%	0 0%	0 0%	0 0%	0 0%
Normal to Slight - Glabella tap	0 0%	0 0%	0 0%	9.1 75.8%	0 0%	0 0%

10. Secondary Outcome

Title	Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Scale (BAS)
Description	Barnes Akathisia Rating Scale (BAS) evaluates observable, restless movements of drug-induced akathisia associated with use of antipsychotic medications, includes objective (1-item) and subjective component (2-items, awareness of movement and distress related to movement) plus Global Clinical Assessment for overall disorder. Components were rated on a 4-point scale for the objective (0 = normal and 3 = constantly restless) and subjective items ((0 = absence of inner restlessness and 3 = awareness of intense compulsion to move for one item; and 0 = no distress and 3 = severe for the other item) and scored on a 6-point scale for the Global Clinical Assessment (0 = absent and 5 = severe). Increases or higher scores indicate a worsening of symptoms. Only incidences of selected shifts of worsening symptoms (an increase in numbers on a scale within the components) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis.
Time Frame	Baseline through Day 17 for Part A

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Barnes Akathisia Scale data.

Arm/Group Title	Aripiprazole	160 mg LY2140023	240 mg LY2140023	320 mg LY2140023	400 mg LY2140023	480 mg LY2140023
Arm/Group Description	Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge).	160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. (Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)	240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.	480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
Measure Participants	16	11	10	11	11	11
Objective - Normal to presence restless movements	0 0%	0 0%	10.0 90.9%	0 0%	0 0%	0 0%
Subjective - Awareness - Absence to non-specific	0 0%	0 0%	10.0 90.9%	9.1 75.8%	9.1 75.8%	9.1 75.8%
Subjective - Distress - No distress to mild	0 0%	0 0%	10.0 90.9%	0 0%	0 0%	0 0%
Global - Absent to questionable	6.3 39.4%	0 0%	10.0 90.9%	9.1 75.8%	9.1 75.8%	9.1 75.8%

Adverse Events

Adverse Event Reporting Description	The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
Arm/Group Title	Aripiprazole		160 mg LY2140023		240 mg LY2140023		320 mg LY2140023		400 mg LY2140023		480 mg LY2140023
Arm/Group Description	Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge).		160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. (Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)		240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.		320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.		400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.		480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
All Cause Mortality
	Aripiprazole		160 mg LY2140023		240 mg LY2140023		320 mg LY2140023		400 mg LY2140023		480 mg LY2140023
	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)
Serious Adverse Events
	Aripiprazole		160 mg LY2140023		240 mg LY2140023		320 mg LY2140023		400 mg LY2140023		480 mg LY2140023
	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	1/16 (6.3%)		0/11 (0%)		1/10 (10%)		0/11 (0%)		0/11 (0%)		0/11 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	0/9 (0%)	0	0/9 (0%)	0	1/9 (11.1%)	1	0/10 (0%)	0	0/11 (0%)	0	0/9 (0%)	0
Psychiatric disorders
Agitation	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Other (Not Including Serious) Adverse Events
	Aripiprazole		160 mg LY2140023		240 mg LY2140023		320 mg LY2140023		400 mg LY2140023		480 mg LY2140023
	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	8/16 (50%)		7/11 (63.6%)		9/10 (90%)		11/11 (100%)		11/11 (100%)		11/11 (100%)
Cardiac disorders
Palpitations	0/16 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Tachycardia	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1	1/11 (9.1%)	1
Eye disorders
Conjunctivitis	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1
Gastrointestinal disorders
Abdominal discomfort	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0	0/11 (0%)	0
Abdominal pain	1/16 (6.3%)	1	1/11 (9.1%)	1	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Constipation	1/16 (6.3%)	2	0/11 (0%)	0	1/10 (10%)	1	1/11 (9.1%)	1	0/11 (0%)	0	0/11 (0%)	0
Diarrhoea	0/16 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Dry mouth	0/16 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Dyspepsia	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Haemorrhoids	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Nausea	0/16 (0%)	0	3/11 (27.3%)	3	8/10 (80%)	9	6/11 (54.5%)	9	4/11 (36.4%)	4	7/11 (63.6%)	13
Paraesthesia oral	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0
Toothache	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0	0/11 (0%)	0
Vomiting	0/16 (0%)	0	0/11 (0%)	0	5/10 (50%)	5	6/11 (54.5%)	11	3/11 (27.3%)	8	9/11 (81.8%)	36
General disorders
Asthenia	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0	0/11 (0%)	0
Energy increased	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/11 (9.1%)	2	0/11 (0%)	0	0/11 (0%)	0
Fatigue	0/16 (0%)	0	2/11 (18.2%)	2	0/10 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1	1/11 (9.1%)	1
Feeling cold	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0
Feeling hot	0/16 (0%)	0	2/11 (18.2%)	2	0/10 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0	0/11 (0%)	0
Feeling of body temperature change	0/16 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0	0/11 (0%)	0
Vessel puncture site pain	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0	0/11 (0%)	0
Infections and infestations
Cellulitis	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0
Urinary tract infection	0/16 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Injury, poisoning and procedural complications
Procedural pain	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Investigations
Blood pressure increased	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1
Electrocardiogram qt prolonged	0/16 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Electroencephalogram abnormal	0/16 (0%)	0	1/11 (9.1%)	2	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	0/16 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Back pain	0/16 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Muscle spasms	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Muscle tightness	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0
Myalgia	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0
Neck pain	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Nervous system disorders
Akathisia	0/16 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Dizziness	0/16 (0%)	0	0/11 (0%)	0	5/10 (50%)	6	6/11 (54.5%)	10	6/11 (54.5%)	10	8/11 (72.7%)	8
Dizziness postural	0/16 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Drooling	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Dysgeusia	0/16 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Dyskinesia	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Dystonia	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	2/11 (18.2%)	2	0/11 (0%)	0	0/11 (0%)	0
Headache	0/16 (0%)	0	1/11 (9.1%)	1	3/10 (30%)	4	4/11 (36.4%)	4	2/11 (18.2%)	2	2/11 (18.2%)	2
Poor quality sleep	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	2/11 (18.2%)	2	0/11 (0%)	0
Presyncope	0/16 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Sedation	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	3	1/11 (9.1%)	1
Somnolence	2/16 (12.5%)	2	0/11 (0%)	0	2/10 (20%)	3	1/11 (9.1%)	1	0/11 (0%)	0	3/11 (27.3%)	3
Syncope	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0	0/11 (0%)	0
Tremor	1/16 (6.3%)	1	1/11 (9.1%)	1	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	2/11 (18.2%)	2
Psychiatric disorders
Abnormal dreams	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	2/11 (18.2%)	2	0/11 (0%)	0
Agitation	0/16 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	1/11 (9.1%)	1	0/11 (0%)	0	1/11 (9.1%)	1
Anticipatory anxiety	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1
Anxiety	2/16 (12.5%)	2	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1
Euphoric mood	0/16 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Insomnia	1/16 (6.3%)	1	1/11 (9.1%)	1	0/10 (0%)	0	2/11 (18.2%)	2	0/11 (0%)	0	0/11 (0%)	0
Psychotic disorder	0/16 (0%)	0	1/11 (9.1%)	1	1/10 (10%)	1	0/11 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1
Renal and urinary disorders
Enuresis	0/16 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Reproductive system and breast disorders
Dysmenorrhoea	0/7 (0%)	0	0/3 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	2/3 (66.7%)	2
Respiratory, thoracic and mediastinal disorders
Cough	0/16 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Dyspnoea	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0	0/11 (0%)	0
Oropharyngeal pain	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0	0/11 (0%)	0
Rhinorrhoea	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Skin and subcutaneous tissue disorders
Dermal cyst	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Dermatitis allergic	1/16 (6.3%)	1	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Hyperhidrosis	0/16 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/11 (0%)	0	0/11 (0%)	0	0/11 (0%)	0
Pruritus	0/16 (0%)	0	1/11 (9.1%)	1	4/10 (40%)	4	2/11 (18.2%)	7	1/11 (9.1%)	1	1/11 (9.1%)	1
Pruritus generalised	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/11 (9.1%)	2	0/11 (0%)	0	0/11 (0%)	0
Vascular disorders
Flushing	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0
Hot flush	0/16 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/11 (9.1%)	1	0/11 (0%)	0

Limitations/Caveats

No analyses were performed and results were not calculated for Part B of this study because the study was stopped prior to Part B being initiated.

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Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.