Trial Outcomes & Findings for Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials (NCT NCT00239356)

Last Updated: 2014-12-19

Results Overview

Baseline is Day 1 of the study, prior to first dose. CGI-S is a questionnaire completed by the clinician which evaluates the severity of mental illness of a participant at a specific point in time. It consists of 7 categories with the lower categories indicating less illness and the higher numbered categories indicating greater severity of illness: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3= mildly ill; 4=moderately ill; 5= markedly ill; 6=severely ill; 7=among the most extremely ill.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

119 participants

Primary outcome timeframe

Baseline to Week 348

Results posted on

2014-12-19

Participant Flow

This study continued to provide aripiprazole post-study to schizophrenic and bipolar I disorder outpatients who had received aripiprazole on other Bristol-Myers Squibb Company (BMS)-sponsored clinical trials.

119 enrolled, 117 treated. Reason(s) for not treated: 2 participants withdrew consent prior to treatment.

Participant milestones

Participant milestones
Measure	Aripiprazole 10 - 30 mg Once Daily (QD) Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.	Aripiprazole 5 - 30 mg QD Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
Overall Study STARTED	97	20
Overall Study COMPLETED	58	11
Overall Study NOT COMPLETED	39	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Aripiprazole 10 - 30 mg Once Daily (QD) Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.	Aripiprazole 5 - 30 mg QD Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
Overall Study Lack of Efficacy	1	0
Overall Study Adverse Event	6	0
Overall Study Withdrawal by Subject	15	6
Overall Study Lost to Follow-up	3	0
Overall Study poor/non-compliance	2	0
Overall Study Pregnancy	1	0
Overall Study Administrative reason	0	1
Overall Study Drug available on market	11	2

Baseline Characteristics

Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline to Week 348

Population: Safety Population - all participants who received at least one dose of drug. N=number of participants who were analyzed at each specific time point. Baseline N=97, 20 for first and second arms, respectively.

Outcome measures

Outcome measures
Measure	Aripiprazole 10 - 30 mg Once Daily (QD) n=97 Participants Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.	Aripiprazole 5 - 30 mg QD n=20 Participants Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population. Baseline	2.6 units on a scale Standard Deviation 0.97	1.0 units on a scale Standard Deviation 0.00
Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population. Week 52 (N=67, 15)	2.3 units on a scale Standard Deviation 0.75	1.1 units on a scale Standard Deviation 0.35
Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population. Week 108 (N=46,15)	2.3 units on a scale Standard Deviation 0.66	1.1 units on a scale Standard Deviation 0.35
Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population. Week 156 (N=26,12)	2.4 units on a scale Standard Deviation 0.80	1.1 units on a scale Standard Deviation 0.29
Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population. Week 212 (N=21,0)	2.1 units on a scale Standard Deviation 0.96	NA units on a scale Standard Deviation NA All participants had dropped out or completed study in the Bipolar Disorder arm.
Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population. Week 260 (N=8,0)	1.9 units on a scale Standard Deviation 1.13	NA units on a scale Standard Deviation NA All participants had dropped out or completed study in the Bipolar Disorder arm.
Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population. Week 316 (N=5,0)	2.4 units on a scale Standard Deviation 1.14	NA units on a scale Standard Deviation NA All participants had dropped out or completed study in the Bipolar Disorder arm.
Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population. Week 348 (N=5,0)	2.4 units on a scale Standard Deviation 1.14	NA units on a scale Standard Deviation NA All participants had dropped out or completed study in the Bipolar Disorder arm.

SECONDARY outcome

Timeframe: Baseline to Week 348

Population: Safety Population: all participants with at least 1 dose of study drug.

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.

Outcome measures

Outcome measures
Measure	Aripiprazole 10 - 30 mg Once Daily (QD) n=97 Participants Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.	Aripiprazole 5 - 30 mg QD n=20 Participants Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population Death	0 participants	0 participants
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population Serious Adverse Events	13 participants	0 participants
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population Adverse Events	47 participants	14 participants
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population Discontinuations due to AEs	6 participants	0 participants

SECONDARY outcome

Timeframe: Day 1 to Day 1170

Population: N=number of participants receiving drug at Days indicated.

Mean exposure is mean number of milligrams per day (mg/day) of aripiprazole administered to the participants.

Outcome measures

Outcome measures
Measure	Aripiprazole 10 - 30 mg Once Daily (QD) n=97 Participants Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.	Aripiprazole 5 - 30 mg QD n=20 Participants Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population Days 541 to 630 (N=57, 17)	20.25 mg/day Interval 10.0 to 30.0	13.53 mg/day Interval 10.0 to 30.0
Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population Days 721 to 810 (N=44, 15)	20.55 mg/day Interval 10.0 to 30.0	13.67 mg/day Interval 10.0 to 30.0
Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population Days 1081 to 1170 (N=27, 12)	23.20 mg/day Interval 10.0 to 60.0	14.7 mg/day Interval 10.0 to 30.0

SECONDARY outcome

Timeframe: Baseline to end of study (Week 348)

Population: Safety Population: all participants with at least 1 dose of study drug. Number of participant analyzed is given as N in each category of laboratory test.

Clinically relevant abnormalities: greater than, equal to (\>=); less than, equal to (\<=). Upper limits of normal (ULN). milligram per deciliter (mg/dL); milliequivalent per liter (mEq/L); nanograms per milliliter (ng/mL);outside of normal range inclusive (): alanine transaminase (ALT\>= 3\*ULN; aspartate aminotransferase (AST \>=3\*ULN; alkaline phosphatase \>=3\*ULN; total bilirubin \>= 2.0 mg/dL; blood urea nitrogen \>= 30mg/dL; calcium (8.40 - 9.90 mg/dL); chloride (85.00 - 108.00 mEq/L); total cholesterol (140.0 - 200.0 mg/dL); cholesterol high density (HDL) and low density (LDL) lipoprotein (39.0 - 116.0 mg/dL); creatine kinase (15.0 - 170.0 U/L); creatinine \>=2.0 mg/dL; prolactin (3.00 - 29.00 ng/mL); sodium (136.0 - 144.0 mEq/L); Glucose fasting (70.0 - 110.0 mg/dL); triglycerides (58.0 - 164.0 mg/dL; uric acid male \>= 10.5, female \>= 8.5mg/dL. Baseline is Day 1 of the study, prior to study drug administration.

Outcome measures

Outcome measures
Measure	Aripiprazole 10 - 30 mg Once Daily (QD) n=97 Participants Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.	Aripiprazole 5 - 30 mg QD n=20 Participants Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Total Bilirubin (N=78, 18)	4 participants	0 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Blood urea nitrogen (N=37, 18)	1 participants	0 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Total Calcium (N=76, 18)	1 participants	0 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Serum chloride (N=62, 17)	1 participants	0 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Cholesterol HDL Fasting (N=44, 13)	17 participants	9 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Cholesterol LDL Fasting (N=47, 13)	13 participants	0 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Total Cholesterol Fasting (N=55, 16)	15 participants	0 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Creatine Kinase (N=64, 18)	2 participants	0 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Creatinine (N=81, 18)	1 participants	0 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Glucose, Fasting serum (N=61, 15)	12 participants	8 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Glucose, serum (N=37, 2)	2 participants	0 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Prolactin (N=63, 18)	8 participants	1 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Sodium, serum (N=76, 17)	1 participants	0 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Triglycerides Fasting (N=59, 16)	17 participants	2 participants
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population Uric Acid (N=71, 17)	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline to end of study (Week 348)

Population: Safety Population: all participants with at least 1 dose of study drug. Number of participant analyzed is given as N in each category of laboratory test.

Clinically relevant laboratory abnormality: Hemoglobin male \<= 11.5 g/dL; female \<= 9.5 g/dL. Hematocrit male \<= 37 and 3 point decrease from baseline (BL); female \<=32 and 3 point decrease from BL. Leukocytes \<= 2800 mm\^3 or \>= 16000 mm\^3; eosinophils \>=10%. Baseline is Day 1 of the study, prior to study drug administration.

Outcome measures

Outcome measures
Measure	Aripiprazole 10 - 30 mg Once Daily (QD) n=97 Participants Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.	Aripiprazole 5 - 30 mg QD n=20 Participants Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population Eosinophils, relative (N=80, 18)	1 participants	3 participants
Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population Hematocrit (N=80, 16)	1 participants	1 participants
Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population Hemoglobin (N=81, 18)	2 participants	1 participants
Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population Leukocytes (N=81, 18)	1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline to end of study (Week 348)

Population: Safety Population: all participants with at least 1 dose of study drug. Number of participants analyzed is given as N in each vital sign parameter and includes those treated participants with vital sign measurements.

Vital signs include standing, sitting and supine systolic and diastolic blood pressure, measured in millimeters of mercury (mmHg) and standing, sitting and supine heart rate, measured in beats per minute. Baseline (BL) is Day 1 of the study, prior to study drug administration. Criteria for identifying vital sign values as clinically relevant: Systolic blood pressure (criterion value=90-180 mmHg) change relative to baseline: increase of greater than, equal to (\>=) 20; decrease of \>= 20 mmHg. Diastolic blood pressure (criterion value=50 - 105 mmHg) change relative to baseline: increase of \>= 15; decrease of \>= 15 mmHg. Heart rate (criterion value=50-120bpm) change relative to baseline: increase \>=15; decreased \>= 15 mmHg. To be clinically significantly abnormal: value must meet the criterion value and also represent a change from the participant's pre-treatment value of at least the magnitude shown in the change relative to baseline.

Outcome measures

Outcome measures
Measure	Aripiprazole 10 - 30 mg Once Daily (QD) n=97 Participants Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.	Aripiprazole 5 - 30 mg QD n=20 Participants Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population Standing Systolic decrease (N=87,18)	3 participants	0 participants
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population Standing Diastolic increase (N=87,18)	1 participants	0 participants
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population Supine Diastolic increase (N=79,20)	1 participants	0 participants
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population Sitting Diastolic increase (N=61,5)	2 participants	0 participants
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population Standing Heart Rate increase (N=87,18)	3 participants	0 participants
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population Orthostatic Hypotension (N=78, 18)	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline to end of study (Week 348

Population: Safety Population: all participants with at least 1 dose of study drug. Number of participants analyzed is given as N in each ECG parameter and includes those treated participants with ECG measurements.

Potentially clinically relevant abnormality or change relative to baseline: sinus tachycardia: \>= 120 beats per minute (bpm) and increased \>= 15 bpm; sinus bradycardia: \<= 50 bpm and decrease \>= 15 bpm; supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter: not present to present. First degree atrioventricular (A-V) block: PR interval(beginner of P wave to beginning of complex of Q, R, and S waves) \>= 0.20 seconds (sec) and increase \>= 0.05 sec; second and third degree A-V block, right bundle branch block (RBB) block, left bundle branch block (LBB) block: not present to present; other intraventricular block: QRS (complex of Q, R and S waves) \>= 0.12 sec and increase \>= 0.02 sec. Myocardial ischemia not present to present. QT interval with Bazett's correction (QTcB) or Fridericia's correction (QTcF) \>= 450 milliseconds (msec) and elevation of 10% over baseline.

Outcome measures

Outcome measures
Measure	Aripiprazole 10 - 30 mg Once Daily (QD) n=97 Participants Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.	Aripiprazole 5 - 30 mg QD n=20 Participants Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population Tachycardia (N=85, 16)	0 participants	1 participants
Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population Bradycardia (N=85, 16)	1 participants	1 participants
Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population Sinus Tachycardia (N=85, 16)	0 participants	1 participants
Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population Sinus Bradycardia (N=85, 16)	1 participants	1 participants
Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population First degree A-V Block (N=85, 16)	10 participants	0 participants
Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population RBB Block (N=85, 16)	1 participants	0 participants
Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population Pre-excitation syndrome (N=85, 16)	1 participants	0 participants
Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population Other intraventricular Block (N=85, 16)	7 participants	2 participants
Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population Myocardial Ischemia (N=85, 16)	1 participants	0 participants
Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population QTcB (N=83, 16)	11 participants	4 participants
Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population QTcF (N=83, 16)	6 participants	0 participants

Adverse Events

Bipolar I Disorder 5 - 30 mg QD

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Schizophrenia 10 - 30 mg QD

Serious events: 13 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bipolar I Disorder 5 - 30 mg QD n=20 participants at risk Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.	Schizophrenia 10 - 30 mg QD n=97 participants at risk Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	1.0% 1/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Psychiatric disorders Anxiety	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	1.0% 1/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Psychiatric disorders Schizophrenia	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	2.1% 2/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Social circumstances Treatment noncompliance	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	1.0% 1/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	1.0% 1/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Psychiatric disorders Alcoholism	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	1.0% 1/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	1.0% 1/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Vascular disorders Hypertension	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	1.0% 1/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Psychiatric disorders Agitation	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	1.0% 1/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Social circumstances Inadequate housing	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	1.0% 1/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Surgical and medical procedures Psychosocial support	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	4.1% 4/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Psychiatric disorders Depression	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	1.0% 1/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Injury, poisoning and procedural complications Overdose	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	1.0% 1/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Renal and urinary disorders Proteinuria	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	1.0% 1/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.

Other adverse events

Other adverse events
Measure	Bipolar I Disorder 5 - 30 mg QD n=20 participants at risk Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.	Schizophrenia 10 - 30 mg QD n=97 participants at risk Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
Infections and infestations Nasopharyngitis	15.0% 3/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	4.1% 4/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Psychiatric disorders Anxiety	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	6.2% 6/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Psychiatric disorders Insomnia	5.0% 1/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	5.2% 5/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
General disorders Pyrexia	35.0% 7/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	1.0% 1/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Respiratory, thoracic and mediastinal disorders Cough	15.0% 3/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	0.00% 0/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Nervous system disorders Headache	30.0% 6/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	6.2% 6/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Gastrointestinal disorders Vomiting	10.0% 2/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	2.1% 2/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Gastrointestinal disorders Nausea	10.0% 2/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	4.1% 4/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Gastrointestinal disorders Constipation	10.0% 2/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	0.00% 0/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/20 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.	7.2% 7/97 • AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included. Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Aripiprazole 10 - 30 mg Once Daily (QD) n=97 Participants Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.	Aripiprazole 5 - 30 mg QD n=20 Participants Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.	Total n=117 Participants Total of all reporting groups
Age, Continuous	39.3 years STANDARD_DEVIATION 11.66 • n=5 Participants	40.3 years STANDARD_DEVIATION 11.78 • n=7 Participants	39.5 years STANDARD_DEVIATION 11.63 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	2 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	18 Participants n=7 Participants	80 Participants n=5 Participants
Region of Enrollment France	24 participants n=5 Participants	0 participants n=7 Participants	24 participants n=5 Participants
Region of Enrollment Hungary	10 participants n=5 Participants	0 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Czech Republic	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Canada	11 participants n=5 Participants	0 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment Poland	7 participants n=5 Participants	0 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Romania	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Croatia	11 participants n=5 Participants	0 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment Russian Federation	9 participants n=5 Participants	0 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment South Africa	8 participants n=5 Participants	0 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Netherlands	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United Kingdom	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Germany	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment India	0 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Israel	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Spain	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Switzerland	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Clinical Global Impression (CGI) Severity	2.6 Units on a scale STANDARD_DEVIATION 0.97 • n=5 Participants	1.0 Units on a scale STANDARD_DEVIATION 0.00 • n=7 Participants	2.3 Units on a scale STANDARD_DEVIATION 1.06 • n=5 Participants