Trial Comparing the Effects of Aripiprazole With Those of Standard of Care on Non-HDL Cholesterol in Patients With Schizophrenia or Bipolar I Disorder Who Have Metabolic Syndrome

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00857818
• Collaborator: (none)
• Enrollment: 64
• Locations: 14
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study was to determine whether patients with schizophrenia, schizoaffective disorder, or bipolar I disorder who also have metabolic syndrome have a larger decrease in fasting non-high density lipoprotein (non-HDL) cholesterol levels with aripiprazole than with their current atypical antipsychotic treatment (olanzapine, risperidone, or quetiapine).

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder; Bipolar I Disorder; Metabolic Syndrome	Drug: Aripiprazole; Drug: Oanzapine, risperidone, or quetiapine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 16-Week, Randomized, Controlled Trial of the Effect of Aripiprazole Versus Standard of Care on Non-HDL Cholesterol Among Patients With Schizophrenia and Bipolar I Disorder Who Have Pre-existing Metabolic Syndrome
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aripiprazole	Drug: Aripiprazole; Aripiprazole administered orally as tablets, 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days within a range of 10 to 30 mg daily, for 16 weeks; Other Names: Abilify BMS-334039
Active Comparator: Control group (Oanzapine, risperidone, or quetiapine)	Drug: Oanzapine, risperidone, or quetiapine; Oanzapine, risperidone, or quetiapine administered orally as tablets at prior dosage for 16 weeks

Outcome Measures

Primary Outcome Measures

1. Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels [Baseline to Weeks 4, 8, and 16]

   Based on Last Observation Carried Forward data. Non-HDL cholesterol is defined as the difference between total cholesterol and high-density lipoprotein (HDL) cholesterol levels. Fasting non-HDL cholesterol is defined as the measured fasting HDL cholesterol level subtracted from the measured fasting total cholesterol level.

2. Mean Baseline Fasting Non-HDL Levels [At baseline (Day 1)]

Secondary Outcome Measures

1. Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs [Baseline to Week 16, continuously]

   AE=any new untoward medical event or worsening of a preexisting medical condition that may or may not be causally related to treatment. SAE=any untoward medical occurrence that at any dose results in death; is life-threatening, a congenital anomaly/birth defect, or an important medical event; requires or prolongs inpatient hospitalization, or results in persistent or significant incapacity or drug dependency or abuse.

2. Mean Percent Changes From Baseline in Fasting Triglyceride and Total, High-Density Lipoprotein, and Low-Density Lipoprotein Cholesterol Levels [Baseline to Week 16]

3. Mean Changes From Baseline in Fasting Glucose Levels [Baseline to Week 16]

4. Percent of Participants Showing a Decrease or Increase in Body Weight of 7% or Greater From Baseline [Baseline and Weeks 4, 8, and 16]

5. Mean Changes From Baseline in Clinical Global Impression-Severity (CGI-S) Scale [Baseline and Weeks 4, 8, and 16]

   The CGI-S scale is a 7-point scale that requires the clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.

6. Number of Participants With Potentially Clinically Relevant Changes From Baseline in Blood Pressure, Heart Rate, Hemoglobin Levels, White Blood Cell Count, Differential Count, and Absolute Platelet Count [Baseline and Weeks 4, 8, and 16]

   Any value falling outside of the normal range will be flagged for the attention of the investigator at the site. The investigator will indicate whether or not a flagged value is of clinical significance.

7. Mean Change From Baseline in Impact of Weight on Quality of Life (IWQoL-Lite) Scores [Baseline to Weeks 4, 8, and 16]

   The IWQoL-Lite is a 31-item self-report survey that assesses the impact of weight on quality of life (QoL) in obese patients. Total score=the sum of scores(ranging from 1-5 for each item) for all 31 items. The sum is then rescaled to a 0-100 scoring, with 0 representing the poorest and 100 the best QoL. The survey also assesses improvements in QoL that occur with weight losses of 5% or greater and deteriorations in QoL with weight gain of 5% or greater. A change of 7.8 to 12.0 points from baseline=meaningful improvement. A change of -4.5 to -7.6 points from baseline=meaningful deterioration.

8. Mean Changes in Weight From Baseline [Baseline to Weeks 4, 8, and 16]

9. Median Changes in Body Mass Index From Baseline [Baseline to Weeks 4, 8, and 16]

10. Mean Changes in Serum Prolactin Levels From Baseline [Baseline to Weeks 4, 8. and 16]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Competency in understanding nature of study and ability to sign informed consent form

• A clinical diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder (manic or mixed) that has been treated with antipsychotics (oral olanzapine, risperidone or quetiapine) for at least 3 months.

• Treatment with any of the antipsychotic medications olanzapine, risperidone, or quetiapine for at least 3 months

• A Clinical Global Impression-Severity Scale score of 4 or lower at baseline

• Confirmed diagnosis of metabolic syndrome

• Patients not receiving treatment specifically for any of the parameters related to metabolic syndrome at the time of randomization

• Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and up to 4 weeks after last dose of investigational product

• Patients for whom it is clinically appropriate to switch from their current atypical antipsychotic to aripiprazole (determined by the investigator)

Exclusion Criteria:

• Risk of suicide (suicidal ideation or recently attempted suicide)

• Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision criteria for any significant psychoactive substance use disorder within 3 months of screening

• Diagnosis of type 1 or 2 diabetes mellitus

• Current treatment for 1 of the components of metabolic syndrome

• Use of medication for the purpose of weight loss

• Diagnosis of bipolar disorders other than bipolar 1, depression with psychotic symptoms, or organic brain syndromes

• History of neuroleptic malignant syndrome

• Diagnosis of Parkinson's disease, Alzheimer's disease, multiple sclerosis, cerebral palsy, epilepsy, or mental retardation

• History of seizures

• Abnormal blood count for platelets, hemoglobin, absolute neutrophils, aspartate aminotransferase, alanine aminotransferase, creatinine, fasting glucose, and thyroid-stimulating hormone

• Electrocardiogram recording with QTc interval >475 msec

• Detectable levels of cocaine or positive screen for stimulants or other drugs considered (determined by the investigator) to be of abuse or dependence

• Blood alcohol levels superior or equal to 50 mg/dL [or 10.9 mmol/L]

• Prior participation in an aripiprazole clinical trial

• Treatment with aripiprazole within 1 month of enrollment

• Predefined exclusionary laboratory tests

• Patients with Bipolar Disorder treated with adjunctive therapy other than a stable dose of mood stabilizers (lithium or valproate) must undergo a 30-day washout period for adjunctive therapies, such as antidepressants, prior to randomization.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Calgary	Alberta	Canada	T2N 2T9
2	Local Institution	Pentincton	British Columbia	Canada	V2A 4M4
3	Local Institution	Vancouver	British Columbia	Canada	V6T 2A1
4	Local Institution	Hamilton	Ontario	Canada	L8N 3K7
5	Local Institution	London	Ontario	Canada	N6H 4V1
6	Local Institution	Markham	Ontario	Canada	L6B 1A1
7	Local Institution	Mississauga	Ontario	Canada	L5M 4N4
8	Local Institution	Toronto	Ontario	Canada	M5T 1R8
9	Local Institution	Toronto	Ontario	Canada	M5T 2S8
10	Local Institution	Montreal	Quebec	Canada	H1N 3M5
11	Local Institution	Montreal	Quebec	Canada	H3A 1A1
12	Local Institution	Montreal	Quebec	Canada	H3M 3A9
13	Local Institution	Montreal	Quebec	Canada	H4H 1R3
14	Local Institution	Quebec		Canada	G1R 2W8

Sponsors and Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00857818
• Other Study ID Numbers: CN138-564
• First Posted: Mar 9, 2009
• Last Update Posted: Dec 2, 2013
• Last Verified: Jul 1, 2011

• Additional relevant MeSH terms: Metabolic Syndrome; Disease; Syndrome; Schizophrenia; Psychotic Disorders; Risperidone; Aripiprazole; Quetiapine Fumarate

Study Results

Participant Flow

Pre-assignment Detail	Of 64 patients enrolled, 36 were screen failures, and 28 were randomized. Of those randomized, 26 received treatment.

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Period Title: Overall Study
STARTED	14	14
Received Treatment	14	12
COMPLETED	3	6
NOT COMPLETED	11	8

Baseline Characteristics

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)	Total
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.	Total of all reporting groups
Overall Participants	14	14	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.0 (10.36)	32.9 (9.10)	35.9 (10.06)
Sex: Female, Male (Count of Participants)
Female	2 14.3%	5 35.7%	7 25%
Male	12 85.7%	9 64.3%	21 75%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 7.1%	1 3.6%
Asian	1 7.1%	1 7.1%	2 7.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 7.1%	0 0%	1 3.6%
White	12 85.7%	12 85.7%	24 85.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels
Description	Based on Last Observation Carried Forward data. Non-HDL cholesterol is defined as the difference between total cholesterol and high-density lipoprotein (HDL) cholesterol levels. Fasting non-HDL cholesterol is defined as the measured fasting HDL cholesterol level subtracted from the measured fasting total cholesterol level.
Time Frame	Baseline to Weeks 4, 8, and 16

Outcome Measure Data

Analysis Population Description

All randomized patients who took at least 1 dose of study medication during the treatment period. The Last Observation Carried Forward (LOCF) data set included data recorded at a given visit. If no observation was recorded at that visit, data was carried forward from the previous visit. .

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Measure Participants	13	12
Week 4	-7.54 (3.22)	0.19 (3.60)
Week 8	-18.45 (2.37)	-4.44 (2.86)
Week 16	-14.72 (3.86)	-2.47 (4.55)

2. Secondary Outcome

Title	Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs
Description	AE=any new untoward medical event or worsening of a preexisting medical condition that may or may not be causally related to treatment. SAE=any untoward medical occurrence that at any dose results in death; is life-threatening, a congenital anomaly/birth defect, or an important medical event; requires or prolongs inpatient hospitalization, or results in persistent or significant incapacity or drug dependency or abuse.
Time Frame	Baseline to Week 16, continuously

Outcome Measure Data

Analysis Population Description

All randomized subjects who took at least 1 dose of study medication during the treatment period.

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Measure Participants	14	14
Deaths	0 0%	0 0%
SAEs	2 14.3%	0 0%
AEs leading to discontinuation	3 21.4%	0 0%
1 or more AEs	11 78.6%	6 42.9%

3. Secondary Outcome

Title	Mean Percent Changes From Baseline in Fasting Triglyceride and Total, High-Density Lipoprotein, and Low-Density Lipoprotein Cholesterol Levels
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Measure Participants	0	0

4. Secondary Outcome

Title	Mean Changes From Baseline in Fasting Glucose Levels
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Measure Participants	0	0

5. Secondary Outcome

Title	Percent of Participants Showing a Decrease or Increase in Body Weight of 7% or Greater From Baseline
Time Frame	Baseline and Weeks 4, 8, and 16

Outcome Measure Data

Analysis Population Description

Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Measure Participants	0	0

6. Secondary Outcome

Title	Mean Changes From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
Description	The CGI-S scale is a 7-point scale that requires the clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.
Time Frame	Baseline and Weeks 4, 8, and 16

Outcome Measure Data

Analysis Population Description

Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Measure Participants	0	0

7. Secondary Outcome

Title	Number of Participants With Potentially Clinically Relevant Changes From Baseline in Blood Pressure, Heart Rate, Hemoglobin Levels, White Blood Cell Count, Differential Count, and Absolute Platelet Count
Description	Any value falling outside of the normal range will be flagged for the attention of the investigator at the site. The investigator will indicate whether or not a flagged value is of clinical significance.
Time Frame	Baseline and Weeks 4, 8, and 16

Outcome Measure Data

Analysis Population Description

Due to low enrollment, this study was terminated early, and these data were not summarized.

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Measure Participants	0	0

8. Secondary Outcome

Title	Mean Change From Baseline in Impact of Weight on Quality of Life (IWQoL-Lite) Scores
Description	The IWQoL-Lite is a 31-item self-report survey that assesses the impact of weight on quality of life (QoL) in obese patients. Total score=the sum of scores(ranging from 1-5 for each item) for all 31 items. The sum is then rescaled to a 0-100 scoring, with 0 representing the poorest and 100 the best QoL. The survey also assesses improvements in QoL that occur with weight losses of 5% or greater and deteriorations in QoL with weight gain of 5% or greater. A change of 7.8 to 12.0 points from baseline=meaningful improvement. A change of -4.5 to -7.6 points from baseline=meaningful deterioration.
Time Frame	Baseline to Weeks 4, 8, and 16

Outcome Measure Data

Analysis Population Description

Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Measure Participants	0	0

9. Secondary Outcome

Title	Mean Changes in Weight From Baseline
Time Frame	Baseline to Weeks 4, 8, and 16

Outcome Measure Data

Analysis Population Description

Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Measure Participants	0	0

10. Secondary Outcome

Title	Median Changes in Body Mass Index From Baseline
Time Frame	Baseline to Weeks 4, 8, and 16

Outcome Measure Data

Analysis Population Description

Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Measure Participants	0	0

11. Secondary Outcome

Title	Mean Changes in Serum Prolactin Levels From Baseline
Time Frame	Baseline to Weeks 4, 8. and 16

Outcome Measure Data

Analysis Population Description

Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Measure Participants	0	0

12. Primary Outcome

Title	Mean Baseline Fasting Non-HDL Levels
Time Frame	At baseline (Day 1)

Outcome Measure Data

Analysis Population Description

All randomized patients who took at least 1 dose of study medication during the treatment period.

Arm/Group Title	Aripiprazole	Control Group (Olanzapine, Risperidone, or Quetiapine)
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Measure Participants	13	12
Mean (Standard Error) [mg/dL]	176.07 (13.76)	167.14 (14.01)

Adverse Events

Arm/Group Title	ARIPIPRAZOLE		CONTROL GROUP
Arm/Group Description	5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.		Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
All Cause Mortality
	ARIPIPRAZOLE		CONTROL GROUP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	ARIPIPRAZOLE		CONTROL GROUP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/14 (14.3%)		0/12 (0%)
Nervous system disorders
NEUROLEPTIC MALIGNANT SYNDROME	1/14 (7.1%)		0/12 (0%)
Psychiatric disorders
HALLUCINATION, VISUAL	1/14 (7.1%)		0/12 (0%)
HALLUCINATION, AUDITORY	1/14 (7.1%)		0/12 (0%)
PSYCHIATRIC DECOMPENSATION	1/14 (7.1%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	ARIPIPRAZOLE		CONTROL GROUP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/14 (78.6%)		6/12 (50%)
Eye disorders
VISION BLURRED	2/14 (14.3%)		0/12 (0%)
Gastrointestinal disorders
NAUSEA	1/14 (7.1%)		1/12 (8.3%)
ABDOMINAL PAIN	0/14 (0%)		1/12 (8.3%)
General disorders
FATIGUE	1/14 (7.1%)		1/12 (8.3%)
FEELING HOT	1/14 (7.1%)		0/12 (0%)
IRRITABILITY	1/14 (7.1%)		0/12 (0%)
Infections and infestations
INFLUENZA	1/14 (7.1%)		0/12 (0%)
TOOTH ABSCESS	1/14 (7.1%)		0/12 (0%)
NASOPHARYNGITIS	1/14 (7.1%)		0/12 (0%)
PHARYNGITIS STREPTOCOCCAL	1/14 (7.1%)		0/12 (0%)
LOWER RESPIRATORY TRACT INFECTION	0/14 (0%)		2/12 (16.7%)
Injury, poisoning and procedural complications
WOUND	0/14 (0%)		1/12 (8.3%)
Investigations
ALANINE AMINOTRANSFERASE INCREASED	1/14 (7.1%)		0/12 (0%)
Metabolism and nutrition disorders
DECREASED APPETITE	1/14 (7.1%)		0/12 (0%)
INCREASED APPETITE	1/14 (7.1%)		0/12 (0%)
Musculoskeletal and connective tissue disorders
PAIN IN JAW	0/14 (0%)		1/12 (8.3%)
MUSCLE RIGIDITY	1/14 (7.1%)		0/12 (0%)
MUSCLE TWITCHING	1/14 (7.1%)		0/12 (0%)
Nervous system disorders
TREMOR	3/14 (21.4%)		0/12 (0%)
HEADACHE	1/14 (7.1%)		0/12 (0%)
AKATHISIA	1/14 (7.1%)		0/12 (0%)
SOMNOLENCE	1/14 (7.1%)		1/12 (8.3%)
PARAESTHESIA	1/14 (7.1%)		0/12 (0%)
EXTRAPYRAMIDAL DISORDER	1/14 (7.1%)		0/12 (0%)
Psychiatric disorders
ANXIETY	2/14 (14.3%)		0/12 (0%)
INSOMNIA	3/14 (21.4%)		0/12 (0%)
AGITATION	1/14 (7.1%)		0/12 (0%)
RESTLESSNESS	1/14 (7.1%)		0/12 (0%)
HALLUCINATION, AUDITORY	1/14 (7.1%)		0/12 (0%)
Respiratory, thoracic and mediastinal disorders
COUGH	1/14 (7.1%)		0/12 (0%)
RHINORRHOEA	1/14 (7.1%)		0/12 (0%)
NASAL CONGESTION	1/14 (7.1%)		0/12 (0%)
SPUTUM DISCOLOURED	1/14 (7.1%)		0/12 (0%)

Limitations/Caveats

The study terminated early due to low enrollment. Mean changes from baseline in: the Clinical Global Impression-Severity Scale and the Impact of Weight on Quality of Life scores were not analyzed due to insufficient data for meaningful conclusions.

More Information

Certain Agreements

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

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.