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A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania

Primary Purpose

Bipolar Disorder

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Lithium or Valproate with placebo (PBO)

Lithium or Valproate with Aripiprazole

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar I Disorder with a recent manic or mixed episode

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men and women > or = to 18 years of age meeting Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, currently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes or sufficient severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

/Active Comparator

Outcomes

Primary Outcome Measures

Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3

Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: hospitalization for a manic, mixed or depressive episode; serious adverse event of worsening disease under study accompanied by a Y-MRS > 16 and/or a MADRS > 16; discontinuation due to lack of efficacy as determined by the investigator accompanied by a Y-MRS > 16 and/or a MADRS > 16.

Secondary Outcome Measures

Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.

Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3

Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: relapse is defined as any of the following events accompanied by a Young-Mania Rating Scale (Y-MRS) >16 and/or a Montgomery Åsberg Depression Rating Scale (MADRS) >16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score >16.

Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3

Kaplan Meier estimated survival rate. Relapse is defined as any of the following events accompanied by a YMRS > 16 and/or a MADRS > 16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score > 16.

Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2

The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. Seven items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the "best" rating and 4 or 8 is the "worst" rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst).

Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3

The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. 7 items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the "best" rating and 4 or 8 is the "worst" rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst).

Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint

The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3

Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2

Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3

Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.

Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3

Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall change from preceding phase items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).

Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2

Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3

Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).

Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).

Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2

Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3

Number of Participants Maintaining Remission During Phase 3

Remission is defined as Y-MRS Total Score <=12 and MADRS Total Score <=12.

Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3)

Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2

Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.

Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2

AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).

Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2

Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate <100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry.

Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2

Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value.

Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2

ULN=upper limit of normal; HDL=high density lipoprotein; LDL=low density lipoprotein. Values for ULN are provided by the lab in the database and could be different for each individual patient based on characteristics such as age, gender, or other patient attributes.

Median Baseline and Change From Baseline in ECG Measurements During Phase 2

Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2

Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2

Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint

Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint

Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample

Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2

Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2

Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid

Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2

Median Baseline Eosinophils (Relative) and Neutrophils (Relative)

Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative)

Median Baseline Hemoglobin

Median Change From Baseline in Hemoglobin

Median Baseline Hematocrit

Median Change From Baseline in Hematocrit

Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta

HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of 'normal function.'

Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR)

HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.'

Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint

Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint

HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.'

Median Baseline Platelet Count

Median Change From Baseline in Platelet Count at Phase 2 Endpoint

Median Baseline Prolactin

Median Change From Baseline in Prolactin at Phase 2 Endpoint

Median Baseline Leukocytes

Median Change From Baseline in Leukocytes at Phase 2 Endpoint

Baseline Abnormal Involuntary Movement Scale (AIMS)

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.

Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint

Baseline in Simpson-Angus Scale (SAS) Total Score

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement.

Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower score=less severe). Negative change scores indicate improvement.

Baseline in Barnes Akathisia Global Clinical Assessment

The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.

Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint

Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3

Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity

Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3

Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3

Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3

Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3

Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3

Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3

Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3

Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3

Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3

Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3

Baseline and Adjusted Mean Change From Baseline in Weight

Number of Participants Showing Relevant Weight Gain During Phase 3

Relevant weight gain: >=7% increase from baseline

Number of Participants Showing Relevant Weight Loss During Phase 3

Relevant weight loss: >=7% decrease from baseline

Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3

Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3

ULN=upper limit of normal; Hb=hemoglobin

Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample

The change values reported are the median of (post baseline percentage (of white blood cell count) minus baseline percentage (of white blood cell count).

Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample

HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.'

Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample

Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3

Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample

Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample

Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower scores=less severe). Negative change scores indicate improvement.

Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample

Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3

Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 8 Score range from 0 to 4. A negative score signifies improvement.

Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 9 Score range from 0 to 4. A negative score signifies improvement.

Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 10 Score range from 0 to 4. A negative score signifies improvement.

Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3

Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3

Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania)

Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint

Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint

Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase

Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase

Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint

Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations

Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase

Metabolic abnormalities considered by the investigator as clinically relevant. (Need normal values for each.)

Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities

Vital sign abnormalities considered by the investigator as clinically relevant.

Extension Phase: Adverse Events (AEs), by Maximum Intensity

Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities

Chemistry, hematology, and urinalysis abnormalities considered by the investigator as clinically relevant. Hematocrit: ≤37%(M)/≤32%(F)+3 percentage pts↓from baseline.

Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities

ECG abnormalities considered by the investigator as clinically relevant.Left Bundle Branch Block: Not present at Baseline--> present post-baseline.

Full Information

NCT ID

NCT00261443

First Posted

December 1, 2005

Last Updated

March 22, 2023

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00261443

Brief Title

A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania

Official Title

Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder

Keywords

Bipolar I Disorder with a recent manic or mixed episode

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1270 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

/Active Comparator

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Lithium or Valproate with placebo (PBO)

Intervention Description

Tablets, Oral, once daily lithium 250-2100 mg/day valproate 250-2500mg/day Placebo once daily

Intervention Type

Drug

Intervention Name(s)

Lithium or Valproate with Aripiprazole

Other Intervention Name(s)

Abilify, BMS-337039

Intervention Description

Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks) lithium 250-2100 mg/day valproate 250-2500mg/day aripiprazole 15-30 mg/day

Primary Outcome Measure Information:

Title

Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3

Description

Time Frame

Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Secondary Outcome Measure Information:

Title

Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3

Description

Time Frame

Baseline (end of Phase 2), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Title

Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3

Description

Time Frame

Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3

Title

Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3

Description

Time Frame

Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3

Title

Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2

Description

Time Frame

Baseline (end of ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, + Confirmation of Partial Nonresponse Phase)

Title

Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3

Description

The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. 7 items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the "best" rating and 4 or 8 is the "worst" rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst).

Time Frame

Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint

Description

Time Frame

Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Title

Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3

Description

Time Frame

Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2

Description

Time Frame

Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Title

Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3

Description

Time Frame

Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2

Description

Time Frame

Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Title

Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3

Description

Time Frame

Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2

Description

Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall change from preceding phase items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).

Time Frame

Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Title

Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2

Description

Time Frame

Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Title

Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3

Description

Time Frame

Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2

Description

Time Frame

Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Title

Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3

Description

Time Frame

Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2

Description

Time Frame

Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Title

Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3

Description

Time Frame

Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Number of Participants Maintaining Remission During Phase 3

Description

Remission is defined as Y-MRS Total Score <=12 and MADRS Total Score <=12.

Time Frame

Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3)

Time Frame

Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2

Description

Time Frame

During Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

Title

Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2

Description

Time Frame

During Phase 2. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Title

Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2

Description

Time Frame

Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

Title

Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2

Description

Time Frame

Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

Title

Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2

Description

Time Frame

Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

Title

Median Baseline and Change From Baseline in ECG Measurements During Phase 2

Time Frame

Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

Title

Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2

Time Frame

Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

Title

Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2

Time Frame

Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

Title

Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint

Time Frame

Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

Title

Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint

Time Frame

Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Title

Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample

Time Frame

Baseline

Title

Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2

Time Frame

Title

Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2

Time Frame

Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

Title

Time Frame

Baseline

Title

Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2

Time Frame

Title

Median Baseline Eosinophils (Relative) and Neutrophils (Relative)

Time Frame

Baseline

Title

Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative)

Time Frame

Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Title

Median Baseline Hemoglobin

Time Frame

Baseline

Title

Median Change From Baseline in Hemoglobin

Time Frame

Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Title

Median Baseline Hematocrit

Time Frame

Baseline

Title

Median Change From Baseline in Hematocrit

Time Frame

Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)

Title

Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta

Description

Time Frame

Baseline

Title

Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR)

Description

HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.'

Time Frame

Baseline

Title

Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint

Description

Time Frame

Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)

Title

Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint

Description

HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.'

Time Frame

Title

Median Baseline Platelet Count

Time Frame

Baseline

Title

Median Change From Baseline in Platelet Count at Phase 2 Endpoint

Time Frame

Title

Median Baseline Prolactin

Time Frame

Baseline

Title

Median Change From Baseline in Prolactin at Phase 2 Endpoint

Time Frame

Title

Median Baseline Leukocytes

Time Frame

Baseline

Title

Median Change From Baseline in Leukocytes at Phase 2 Endpoint

Time Frame

Title

Baseline Abnormal Involuntary Movement Scale (AIMS)

Description

Time Frame

Baseline

Title

Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint

Description

Time Frame

Title

Baseline in Simpson-Angus Scale (SAS) Total Score

Description

Time Frame

Baseline

Title

Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint

Description

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower score=less severe). Negative change scores indicate improvement.

Time Frame

Title

Baseline in Barnes Akathisia Global Clinical Assessment

Description

Time Frame

Baseline

Title

Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint

Description

Time Frame

Title

Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3

Description

Time Frame

Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity

Description

Time Frame

Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3

Description

Time Frame

Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3

Time Frame

Baseline, During Phase 3 (for highest/lowest values), Week 52

Title

Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3

Time Frame

Baseline, During Phase 3 (for highest/lowest values), Week 52

Title

Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3

Time Frame

Baseline, During Phase 3 (for highest/lowest values), Week 52

Title

Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3

Time Frame

Baseline, During Phase 3 (for highest/lowest values), Week 52

Title

Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3

Time Frame

Baseline, During Phase 3 (for highest/lowest values), Week 52

Title

Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3

Time Frame

Baseline, During Phase 3 (for highest/lowest values), Week 52

Title

Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3

Time Frame

Baseline, During Phase 3 (for highest/lowest values), Week 52

Title

Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3

Time Frame

Baseline, During Phase 3 (for highest/lowest values), Week 52

Title

Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3

Time Frame

Baseline, During Phase 3 (for highest/lowest values), Week 52

Title

Baseline and Adjusted Mean Change From Baseline in Weight

Time Frame

Baseline, Weeks 12, 24, 36, 52, During Phase 3 (for highest value)

Title

Number of Participants Showing Relevant Weight Gain During Phase 3

Description

Relevant weight gain: >=7% increase from baseline

Time Frame

Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)

Title

Number of Participants Showing Relevant Weight Loss During Phase 3

Description

Relevant weight loss: >=7% decrease from baseline

Time Frame

Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)

Title

Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3

Time Frame

Baseline, Week 12, Week 24, Week 36, Week 52, Week 52 (LOCF), During Phase 3 (for lowest/highest values)

Title

Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3

Description

ULN=upper limit of normal; Hb=hemoglobin

Time Frame

Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample

Description

The change values reported are the median of (post baseline percentage (of white blood cell count) minus baseline percentage (of white blood cell count).

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)

Title

Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)

Title

Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value

Title

Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample

Description

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value

Title

Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample

Description

HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.'

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value

Title

Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)

Title

Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3

Description

Time Frame

Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3

Description

The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower scores=less severe). Negative change scores indicate improvement.

Time Frame

Baseline, Weeks 4,8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)

Title

Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample

Time Frame

Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)

Title

Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3

Description

Time Frame

Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)

Title

Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3

Description

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 8 Score range from 0 to 4. A negative score signifies improvement.

Time Frame

Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)

Title

Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3

Description

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 9 Score range from 0 to 4. A negative score signifies improvement.

Time Frame

Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)

Title

Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3

Description

The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 10 Score range from 0 to 4. A negative score signifies improvement.

Time Frame

Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)

Title

Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3

Description

Time Frame

Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)

Title

Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3

Time Frame

Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania)

Description

Time Frame

Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 of LTE Phase. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint

Description

Time Frame

Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint

Description

Time Frame

Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase

Description

Time Frame

Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase

Description

Time Frame

Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint

Description

Time Frame

Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations

Description

Time Frame

From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])

Title

Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase

Description

Metabolic abnormalities considered by the investigator as clinically relevant. (Need normal values for each.)

Time Frame

Title

Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities

Description

Vital sign abnormalities considered by the investigator as clinically relevant.

Time Frame

Title

Extension Phase: Adverse Events (AEs), by Maximum Intensity

Description

Time Frame

Title

Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities

Description

Chemistry, hematology, and urinalysis abnormalities considered by the investigator as clinically relevant. Hematocrit: ≤37%(M)/≤32%(F)+3 percentage pts↓from baseline.

Time Frame

Title

Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities

Description

ECG abnormalities considered by the investigator as clinically relevant.Left Bundle Branch Block: Not present at Baseline--> present post-baseline.

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Tuscaloosa Va Medical Center

City

Tuscaloosa

State/Province

Alabama

ZIP/Postal Code

35404

Country

United States

Facility Name

Pravin Kansagra, M.D.

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Psychopharmacology Research Network Of Torrance

City

Cerritos

State/Province

California

ZIP/Postal Code

90703

Country

United States

Facility Name

Atp Clinical Research, Inc.

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

Country

United States

Facility Name

Us Clinical Research Centers, Llc

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92627

Country

United States

Facility Name

Va Long Beach Healthcare System

City

Long Beach

State/Province

California

ZIP/Postal Code

90822

Country

United States

Facility Name

Synergy Clinical Research Center

City

National City

State/Province

California

ZIP/Postal Code

91950

Country

United States

Facility Name

University Of California, Irvine Medical Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Clinical Neuroscience Solutions, Inc.

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

University Of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Carman Research

City

Smyrna

State/Province

Georgia

ZIP/Postal Code

30080

Country

United States

Facility Name

University Of Massachusetts Medical School

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Psych Care Consultants Research

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Cns Research Institute, P.C.

City

Clementon

State/Province

New Jersey

ZIP/Postal Code

08021

Country

United States

Facility Name

Neuropsychiatric Research Associates

City

New York

State/Province

New York

ZIP/Postal Code

10128

Country

United States

Facility Name

Behavioral Medical Research Of Staten Island

City

Staten Island

State/Province

New York

ZIP/Postal Code

10305

Country

United States

Facility Name

Richmond Behavioral Associates

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

Psychiatry And Clinical Research

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

Rakesh Ranjan, Md & Associates, Inc.

City

Beachwood

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

University Of Cincinnati Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

Metro Health Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

Facility Name

Midwest Clinical Research Center

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45408

Country

United States

Facility Name

Portland Va Medical Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97201

Country

United States

Facility Name

Senior Adults Specialty Research, Inc.

City

Austin

State/Province

Texas

ZIP/Postal Code

78757

Country

United States

Facility Name

Futuresearch Trials

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Insite Clinical Research

City

DeSoto

State/Province

Texas

ZIP/Postal Code

75115

Country

United States

Facility Name

Red Oak Psychiatry Associates, Pa

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

University Of Utah School Of Medicine

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Northwest Clinical Research Center

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98004

Country

United States

Facility Name

Local Institution

City

Salvador

State/Province

Bahia

ZIP/Postal Code

40325

Country

Brazil

Facility Name

Local Institution

City

Aparecida De Goinia

State/Province

Goias

ZIP/Postal Code

74922

Country

Brazil

Facility Name

Local Institution

City

Pelotas

State/Province

Rio Grande Do Sul

ZIP/Postal Code

96030 003

Country

Brazil

Facility Name

Local Institution

City

Rio De Janeiro

ZIP/Postal Code

21020

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

02340

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

05403

Country

Brazil

Facility Name

Local Institution

City

Bourgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

Local Institution

City

Rousse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Local Institution

City

Rijeka

ZIP/Postal Code

51-000

Country

Croatia

Facility Name

Local Institution

City

Split

ZIP/Postal Code

21000

Country

Croatia

Facility Name

Local Institution

City

Zadar

ZIP/Postal Code

23000

Country

Croatia

Facility Name

Local Institution

City

Zagreb

ZIP/Postal Code

10 090

Country

Croatia

Facility Name

Local Institution

City

Brno

ZIP/Postal Code

610 00

Country

Czechia

Facility Name

Local Institution

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Local Institution

City

Havirov

ZIP/Postal Code

736 01

Country

Czechia

Facility Name

Local Institution

City

Litomerice

ZIP/Postal Code

412 01

Country

Czechia

Facility Name

Local Institution

City

Prague 2

ZIP/Postal Code

120 00

Country

Czechia

Facility Name

Local Institution

City

Praha 6

ZIP/Postal Code

160 00

Country

Czechia

Facility Name

Local Institution

City

Prerov

ZIP/Postal Code

75002

Country

Czechia

Facility Name

Local Institution

City

Nantes

State/Province

Cedex 01

ZIP/Postal Code

44035

Country

France

Facility Name

Local Institution

City

Dole

ZIP/Postal Code

39100

Country

France

Facility Name

Local Institution

City

Henin Beaumont

ZIP/Postal Code

62251

Country

France

Facility Name

Local Institution

City

Jonzac Cedex

ZIP/Postal Code

175003

Country

France

Facility Name

Local Institution

City

La Seyne Sur Mer

ZIP/Postal Code

83500

Country

France

Facility Name

Local Institution

City

Marseille

ZIP/Postal Code

13009

Country

France

Facility Name

Local Institution

City

Nantes

ZIP/Postal Code

44000

Country

France

Facility Name

Local Institution

City

Nimes

ZIP/Postal Code

30900

Country

France

Facility Name

Local Institution

City

Rennes

ZIP/Postal Code

35000

Country

France

Facility Name

Local Institution

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500 034

Country

India

Facility Name

Local Institution

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380 006

Country

India

Facility Name

Local Institution

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

6577647

Country

India

Facility Name

Local Institution

City

Kalyan (West)

State/Province

Maharashtra

ZIP/Postal Code

421 301

Country

India

Facility Name

Local Institution

City

Nagur

State/Province

Maharashtra

ZIP/Postal Code

440010

Country

India

Facility Name

Local Institution

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

400 001

Country

India

Facility Name

Local Institution

City

Mangalore

State/Province

Manipal

ZIP/Postal Code

576 104

Country

India

Facility Name

Local Institution

City

Mumbai

State/Province

Sion (W)

ZIP/Postal Code

400 022

Country

India

Facility Name

Local Institution

City

Delhi

ZIP/Postal Code

110 092

Country

India

Facility Name

Local Institution

City

Hyderabad

ZIP/Postal Code

500 038

Country

India

Facility Name

Local Institution

City

Mumbai

ZIP/Postal Code

400 008

Country

India

Facility Name

Local Institution

City

Mumbai

ZIP/Postal Code

400 058

Country

India

Facility Name

Local Institution

City

New Delhi

ZIP/Postal Code

110 002

Country

India

Facility Name

Local Institution

City

New Delhi

ZIP/Postal Code

110 065

Country

India

Facility Name

Local Institution

City

Izhevsk

ZIP/Postal Code

426053

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

107258

Country

Russian Federation

Facility Name

Local Institution

City

Nizhny Novgorod

ZIP/Postal Code

603107

Country

Russian Federation

Facility Name

Local Institution

City

Saint-Petersburg

ZIP/Postal Code

191119

Country

Russian Federation

Facility Name

Local Institution

City

Saratov

ZIP/Postal Code

410028

Country

Russian Federation

Facility Name

Local Institution

City

St-Petersburg

ZIP/Postal Code

190000

Country

Russian Federation

Facility Name

Local Institution

City

Tomsk

ZIP/Postal Code

634014

Country

Russian Federation

Facility Name

Local Institution

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0001

Country

South Africa

Facility Name

Local Institution

City

Berea

State/Province

Kwa Zulu Natal

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Local Institution

City

Durban

State/Province

Kwa Zulu Natal

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Local Institution

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7708

Country

South Africa

Facility Name

Local Institution

City

Paarl

State/Province

Western Cape

ZIP/Postal Code

7646

Country

South Africa

12. IPD Sharing Statement

Citations:

PubMed Identifier

21443567

Citation

Marcus R, Khan A, Rollin L, Morris B, Timko K, Carson W, Sanchez R. Efficacy of aripiprazole adjunctive to lithium or valproate in the long-term treatment of patients with bipolar I disorder with an inadequate response to lithium or valproate monotherapy: a multicenter, double-blind, randomized study. Bipolar Disord. 2011 Mar;13(2):133-44. doi: 10.1111/j.1399-5618.2011.00898.x.

Results Reference

derived

Learn more about this trial

A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania

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A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania

Bipolar Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial