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

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00261443
First received: December 1, 2005
Last updated: April 8, 2011
Last verified: April 2011
History of Changes
Results First Received: January 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Drug: Lithium or Valproate with placebo (PBO)
Drug: Lithium or Valproate with Aripiprazole

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pre-Randomized Participants Phase 1 (2 to 8 Week Screening, Washout and Confirmation of Partial Nonresponse Phase): lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml. Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
Placebo Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
Aripiprazole Phase 3 (52 Week Assessment of Relapse Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.

Participant Flow for 4 periods

 Period 1:   1: Confirmation of Partial Nonresponse
    Pre-Randomized Participants     Placebo     Aripiprazole  
STARTED     1270     0     0  
COMPLETED     686     0     0  
NOT COMPLETED     584     0     0  
Adverse Event                 33                 0                 0  
Withdrawal by Subject                 93                 0                 0  
Lost to Follow-up                 111                 0                 0  
Poor/Noncompliance                 23                 0                 0  
Pregnancy                 1                 0                 0  
Subject No Longer Met Study Criteria                 307                 0                 0  
Other Reasons                 16                 0                 0  

Period 2:   2: Stability & Maintenance of Stability
    Pre-Randomized Participants     Placebo     Aripiprazole  
STARTED     686     0     0  
COMPLETED     346     0     0  
NOT COMPLETED     340     0     0  
Lack of Efficacy                 43                 0                 0  
Adverse Event                 93                 0                 0  
Withdrawal by Subject                 65                 0                 0  
Lost to Follow-up                 59                 0                 0  
Poor/Noncompliance                 33                 0                 0  
Pregnancy                 1                 0                 0  
subject No Longer Met Study Criteria                 32                 0                 0  
Administrative Reason by Sponsor                 1                 0                 0  
Other Reasons                 13                 0                 0  

Period 3:   3: Assessment of Relapse
    Pre-Randomized Participants     Placebo     Aripiprazole  
STARTED     0     169     168  
COMPLETED     0     89     103  
NOT COMPLETED     0     80     65  
Lack of Efficacy                 0                 31                 14  
Adverse Event                 0                 15                 19  
Withdrawal by Subject                 0                 14                 15  
Death                 0                 0                 1  
Lost to Follow-up                 0                 7                 6  
Poor/Noncompliance                 0                 5                 3  
Pregnancy                 0                 2                 1  
Subject No Longer Meets Study Criteria                 0                 2                 1  
Administrative Reason By Sponsor                 0                 0                 2  
Other Reasons                 0                 4                 3  

Period 4:   4: Extension Phase
    Pre-Randomized Participants     Placebo     Aripiprazole  
STARTED     0     19     23  
COMPLETED     0     16     21  
NOT COMPLETED     0     3     2  
Adverse Event                 0                 1                 0  
Withdrawal by Subject                 0                 1                 2  
Lost to Follow-up                 0                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Placebo Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
Aripiprazole Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
Total Total of all reporting groups

Baseline Measures
    Placebo     Aripiprazole     Total  
Number of Participants  
[units: participants]
 		  169     168     337  
Age  
[units: years]
Mean ± Standard Deviation 		  38.8  ± 12.29     39.2  ± 12.43     39.0  ± 12.34  
Gender  
[units: participants]
 		     
Female     98     87     185  
Male     71     81     152  
Race/Ethnicity, Customized  
[units: participants]
 		     
White     112     118     230  
Black/African American     19     12     31  
Asian     33     34     67  
Other     5     4     9  
Race/Ethnicity, Customized  
[units: Participants]
 		     
Hispanic/Latino     3     5     8  
Not Hispanic or Latino     55     56     111  
Non-US     111     107     218  
Region of Enrollment  
[units: participants]
 		     
France     8     9     17  
United States     58     61     119  
Czech Republic     18     14     32  
Brazil     28     27     55  
Croatia     3     4     7  
Russian Federation     17     15     32  
South Africa     4     4     8  
India     33     34     67  
Body Mass Index (BMI) Category [1]
[units: Participants]
 		     
<18.5 kg/m^2     5     0     5  
18.5 kg/m^2 to <25 kg/m^2     58     49     107  
25 kg/m^2 to <30 kg/m^2     50     63     113  
>= 30 kg/m^2     56     56     112  
Body Mass Index (BMI) [1]
[units: kg/m^2]
Mean ± Standard Deviation 		  28.7  ± 7.72     28.5  ± 6.00     28.6  ± 6.90  
CGI-BP Change from Preceding Phase Score (Depression) [2]
[units: units on a scale]
Mean ± Standard Deviation 		  3.0  ± 1.34     3.0  ± 1.31     3.0  ± 1.32  
CGI-BP Change from Preceding Phase Score (Mania) [2]
[units: units on a scale]
Mean ± Standard Deviation 		  1.6  ± 0.81     1.4  ± 0.63     1.5  ± 0.72  
CGI-BP Change from Preceding Phase Score (Overall) [2]
[units: units on a scale]
Mean ± Standard Deviation 		  1.6  ± 0.85     1.5  ± 0.69     1.6  ± 0.77  
CGI-BP Severity of Illness Score (Depression) [3]
[units: units on a scale]
Mean ± Standard Deviation 		  1.3  ± 0.57     1.4  ± 0.70     1.4  ± 0.64  
CGI-BP Severity of Illness Score (Mania) [3]
[units: units on a scale]
Mean ± Standard Deviation 		  1.5  ± 0.72     1.5  ± 0.72     1.5  ± 0.72  
CGI-BP Severity of Illness Score (Overall) [3]
[units: units on a scale]
Mean ± Standard Deviation 		  1.6  ± 0.76     1.7  ± 0.83     1.6  ± 0.79  
Montgomery Åsberg Depression Rating Scale (MADRS) Total Score [4]
[units: units on a scale]
Mean ± Standard Deviation 		  3.7  ± 3.45     4.1  ± 3.82     3.9  ± 3.64  
Weight  
[units: kg]
Mean ± Standard Deviation 		  81.3  ± 25.11     80.6  ± 18.89     81.0  ± 22.20  
Young-Mania Rating Scale (Y-MRS) Total Score [5]
[units: units on a scale]
Mean ± Standard Deviation 		  4.1  ± 3.31     4.1  ± 3.56     4.1  ± 3.43  
[1] BMI is defined as weight in kilograms divided by the square of height in meters.
[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).
[3] Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Severity of Illness (mania, depression, and overall bipolar illness) items (a 7-point scale from 1 to 7, with 1 being normal, not ill and 7 being very severely ill).
[4] MADRS consists of 10-items, ordinal rating scale The possible total scores are from 0 to 60 (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
[5] 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 to 60.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3   [ 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]) ]
  Show Outcome Measure 1

2.  Secondary:   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   [ Time Frame: Baseline (end of Phase 2), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
  Show Outcome Measure 2

3.  Secondary:   Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3   [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3 ]
  Show Outcome Measure 3

4.  Secondary:   Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3   [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3 ]
  Show Outcome Measure 4

5.  Secondary:   Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2   [ 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) ]
  Show Outcome Measure 5

6.  Secondary:   Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3   [ 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]) ]
  Show Outcome Measure 6

7.  Secondary:   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   [ 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) ]
  Show Outcome Measure 7

8.  Secondary:   Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3   [ 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]) ]
  Show Outcome Measure 8

9.  Secondary:   Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2   [ 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) ]
  Show Outcome Measure 9

10.  Secondary:   Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3   [ 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]) ]
  Show Outcome Measure 10

11.  Secondary:   Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2   [ 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) ]
  Show Outcome Measure 11

12.  Secondary:   Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3   [ 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]) ]
  Show Outcome Measure 12

13.  Secondary:   Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2   [ 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) ]
  Show Outcome Measure 13

14.  Secondary:   Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2   [ 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) ]
  Show Outcome Measure 14

15.  Secondary:   Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3   [ 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]) ]
  Show Outcome Measure 15

16.  Secondary:   Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2   [ 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) ]
  Show Outcome Measure 16

17.  Secondary:   Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3   [ 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]) ]
  Show Outcome Measure 17

18.  Secondary:   Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2   [ 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) ]
  Show Outcome Measure 18

19.  Secondary:   Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3   [ 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]) ]
  Hide Outcome Measure 19

Measure Type Secondary
Measure Title Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Measure Description 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).
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])  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.

Reporting Groups
  Description
Placebo Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
Aripiprazole Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets

Measured Values
    Placebo     Aripiprazole  
Number of Participants Analyzed  
[units: participants]
 		  164     162  
Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3  
[units: units on a scale]
Mean ± Standard Error 		   
Mean Change at Week 4 (n=160, 162)     3.17  ± 0.113     3.27  ± 0.110  
Mean Change at Week 8     3.36  ± 0.118     3.22  ± 0.116  
Mean Change at Week 12     3.34  ± 0.122     3.27  ± 0.120  
Mean Change at Week 16     3.45  ± 0.121     3.22  ± 0.119  
Mean Change at Week 20     3.53  ± 0.125     3.31  ± 0.122  
Mean Change at Week 24     3.60  ± 0.127     3.31  ± 0.125  
Mean Change at Week 28     3.65  ± 0.130     3.31  ± 0.127  
Mean Change at Week 32     3.63  ± 0.130     3.29  ± 0.128  
Mean Change at Week 36     3.61  ± 0.132     3.28  ± 0.130  
Mean Change at Week 40     3.54  ± 0.133     3.24  ± 0.131  
Mean Change at Week 44     3.57  ± 0.135     3.28  ± 0.132  
Mean Change at Week 48     3.63  ± 0.136     3.26  ± 0.134  
Mean Change at Week 52     3.58  ± 0.138     3.25  ± 0.135  


Statistical Analysis 1 for Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Groups [1] All groups
Method [2] ANOVA/ANCOVA
P Value [3] 0.488
Difference [4] 0.10
95% Confidence Interval ( -0.19 to 0.40 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aripiprazole - Placebo; Week 4 Comparison
[2] Other relevant information, such as adjustments or degrees of freedom:
  Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Groups [1] All groups
Method [2] ANOVA/ANCOVA
P Value [3] 0.349
Difference [4] -0.15
95% Confidence Interval ( -0.46 to 0.16 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aripiprazole - Placebo; Week 8 Comparison
[2] Other relevant information, such as adjustments or degrees of freedom:
  Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Groups [1] All groups
Method [2] ANOVA/ANCOVA
P Value [3] 0.653
Difference [4] -0.07
95% Confidence Interval ( -0.39 to 0.25 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aripiprazole - Placebo; Week 12 Comparison
[2] Other relevant information, such as adjustments or degrees of freedom:
  Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Groups [1] All groups
Method [2] ANOVA/ANCOVA
P Value [3] 0.141
Difference [4] -0.24
95% Confidence Interval ( -0.56 to 0.08 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aripiprazole - Placebo; Week 16 Comparison
[2] Other relevant information, such as adjustments or degrees of freedom:
  Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Groups [1] All groups
Method [2] ANOVA/ANCOVA
P Value [3] 0.196
Difference [4] -0.22
95% Confidence Interval ( -0.54 to 0.11 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aripiprazole - Placebo; Week 20 Comparison
[2] Other relevant information, such as adjustments or degrees of freedom:
  Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Groups [1] All groups
Method [2] ANOVA/ANCOVA
P Value [3] 0.088
Difference [4] -0.29
95% Confidence Interval ( -0.62 to 0.04 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aripiprazole - Placebo; Week 24 Comparison
[2] Other relevant information, such as adjustments or degrees of freedom:
  Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Groups [1] All groups
Method [2] ANOVA/ANCOVA
P Value [3] 0.047
Difference [4] -0.34
95% Confidence Interval ( -0.68 to -0.01 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aripiprazole - Placebo; Week 28 Comparison
[2] Other relevant information, such as adjustments or degrees of freedom:
  Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Groups [1] All groups
Method [2] ANOVA/ANCOVA
P Value [3] 0.057
Difference [4] -0.33
95% Confidence Interval ( -0.67 to 0.01 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aripiprazole - Placebo; Week 32 Comparison
[2] Other relevant information, such as adjustments or degrees of freedom:
  Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Groups [1] All groups
Method [2] ANOVA/ANCOVA
P Value [3] 0.063
Difference [4] -0.33
95% Confidence Interval ( -0.68 to 0.02 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aripiprazole - Placebo; Week 36 Comparison
[2] Other relevant information, such as adjustments or degrees of freedom:
  Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Groups [1] All groups
Method [2] ANOVA/ANCOVA
P Value [3] 0.091
Difference [4] -0.30
95% Confidence Interval ( -0.65 to 0.05 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aripiprazole - Placebo; Week 40 Comparison
[2] Other relevant information, such as adjustments or degrees of freedom:
  Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Groups [1] All groups
Method [2] ANOVA/ANCOVA
P Value [3] 0.105
Difference [4] -0.29
95% Confidence Interval ( -0.64 to 0.06 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aripiprazole - Placebo; Week 44 Comparison
[2] Other relevant information, such as adjustments or degrees of freedom:
  Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 12 for Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Groups [1] All groups
Method [2] ANOVA/ANCOVA
P Value [3] 0.047
Difference [4] -0.36
95% Confidence Interval ( -0.72 to -0.01 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aripiprazole - Placebo; Week 48 Comparison
[2] Other relevant information, such as adjustments or degrees of freedom:
  Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 13 for Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Groups [1] All groups
Method [2] ANOVA/ANCOVA
P Value [3] 0.073
Difference [4] -0.33
95% Confidence Interval ( -0.69 to 0.03 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aripiprazole - Placebo; Week 52 Comparison
[2] Other relevant information, such as adjustments or degrees of freedom:
  Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.
[4] Other relevant estimation information:
  No text entered.



20.  Secondary:   Number of Participants Maintaining Remission During Phase 3   [ 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]) ]
  Show Outcome Measure 20

21.  Secondary:   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]) ]
  Show Outcome Measure 21

22.  Secondary:   Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2   [ 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) ]
  Show Outcome Measure 22

23.  Secondary:   Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2   [ 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) ]
  Show Outcome Measure 23

24.  Secondary:   Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2   [ 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) ]
  Show Outcome Measure 24

25.  Secondary:   Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2   [ 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) ]
  Show Outcome Measure 25

26.  Secondary:   Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2   [ 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) ]
  Show Outcome Measure 26

27.  Secondary:   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) ]
  Show Outcome Measure 27

28.  Secondary:   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) ]
  Show Outcome Measure 28

29.  Secondary:   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) ]
  Show Outcome Measure 29

30.  Secondary:   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) ]
  Show Outcome Measure 30

31.  Secondary:   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) ]
  Show Outcome Measure 31

32.  Secondary:   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 ]
  Show Outcome Measure 32

33.  Secondary:   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: 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) ]
  Show Outcome Measure 33

34.  Secondary:   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) ]
  Show Outcome Measure 34

35.  Secondary:   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   [ Time Frame: Baseline ]
  Show Outcome Measure 35

36.  Secondary:   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: 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) ]
  Show Outcome Measure 36

37.  Secondary:   Median Baseline Eosinophils (Relative) and Neutrophils (Relative)   [ Time Frame: Baseline ]
  Show Outcome Measure 37

38.  Secondary:   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) ]
  Show Outcome Measure 38

39.  Secondary:   Median Baseline Hemoglobin   [ Time Frame: Baseline ]
  Show Outcome Measure 39

40.  Secondary:   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) ]
  Show Outcome Measure 40

41.  Secondary:   Median Baseline Hematocrit   [ Time Frame: Baseline ]
  Show Outcome Measure 41

42.  Secondary:   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) ]
  Show Outcome Measure 42

43.  Secondary:   Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta   [ Time Frame: Baseline ]
  Show Outcome Measure 43

44.  Secondary:   Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR)   [ Time Frame: Baseline ]
  Show Outcome Measure 44

45.  Secondary:   Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint   [ 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) ]
  Show Outcome Measure 45

46.  Secondary:   Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint   [ 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) ]
  Show Outcome Measure 46

47.  Secondary:   Median Baseline Platelet Count   [ Time Frame: Baseline ]
  Show Outcome Measure 47

48.  Secondary:   Median Change From Baseline in Platelet Count 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) ]
  Show Outcome Measure 48

49.  Secondary:   Median Baseline Prolactin   [ Time Frame: Baseline ]
  Show Outcome Measure 49

50.  Secondary:   Median Change From Baseline in Prolactin 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) ]
  Show Outcome Measure 50

51.  Secondary:   Median Baseline Leukocytes   [ Time Frame: Baseline ]
  Show Outcome Measure 51

52.  Secondary:   Median Change From Baseline in Leukocytes 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) ]
  Show Outcome Measure 52

53.  Secondary:   Baseline Abnormal Involuntary Movement Scale (AIMS)   [ Time Frame: Baseline ]
  Show Outcome Measure 53

54.  Secondary:   Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) 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) ]
  Show Outcome Measure 54

55.  Secondary:   Baseline in Simpson-Angus Scale (SAS) Total Score   [ Time Frame: Baseline ]
  Show Outcome Measure 55

56.  Secondary:   Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score 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) ]
  Show Outcome Measure 56

57.  Secondary:   Baseline in Barnes Akathisia Global Clinical Assessment   [ Time Frame: Baseline ]
  Show Outcome Measure 57

58.  Secondary:   Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment 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) ]
  Show Outcome Measure 58

59.  Secondary:   Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation 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]) ]
  Show Outcome Measure 59

60.  Secondary:   Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity   [ 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]) ]
  Show Outcome Measure 60

61.  Secondary:   Participants With Potentially Clinically Relevant Vital Sign Abnormalities 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]) ]
  Show Outcome Measure 61

62.  Secondary:   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 ]
  Show Outcome Measure 62

63.  Secondary:   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 ]
  Show Outcome Measure 63

64.  Secondary:   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 ]
  Show Outcome Measure 64

65.  Secondary:   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 ]
  Show Outcome Measure 65

66.  Secondary:   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 ]
  Show Outcome Measure 66

67.  Secondary:   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 ]
  Show Outcome Measure 67

68.  Secondary:   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 ]
  Show Outcome Measure 68

69.  Secondary:   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 ]
  Show Outcome Measure 69

70.  Secondary:   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 ]
  Show Outcome Measure 70

71.  Secondary:   Baseline and Adjusted Mean Change From Baseline in Weight   [ Time Frame: Baseline, Weeks 12, 24, 36, 52, During Phase 3 (for highest value) ]
  Show Outcome Measure 71

72.  Secondary:   Number of Participants Showing Relevant Weight Gain During Phase 3   [ Time Frame: Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment) ]
  Show Outcome Measure 72

73.  Secondary:   Number of Participants Showing Relevant Weight Loss During Phase 3   [ Time Frame: Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment) ]
  Show Outcome Measure 73

74.  Secondary:   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) ]
  Show Outcome Measure 74

75.  Secondary:   Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities 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]) ]
  Show Outcome Measure 75

76.  Secondary:   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) ]
  Show Outcome Measure 76

77.  Secondary:   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) ]
  Show Outcome Measure 77

78.  Secondary:   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) ]
  Show Outcome Measure 78

79.  Secondary:   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) ]
  Show Outcome Measure 79

80.  Secondary:   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) ]
  Show Outcome Measure 80

81.  Secondary:   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) ]
  Show Outcome Measure 81

82.  Secondary:   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) ]
  Show Outcome Measure 82

83.  Secondary:   Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample   [ Time Frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) ]
  Show Outcome Measure 83

84.  Secondary:   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) ]
  Show Outcome Measure 84

85.  Secondary:   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) ]
  Show Outcome Measure 85

86.  Secondary:   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) ]
  Show Outcome Measure 86

87.  Secondary:   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 ]
  Show Outcome Measure 87

88.  Secondary:   Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample   [ Time Frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value ]
  Show Outcome Measure 88

89.  Secondary:   Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample   [ Time Frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value ]
  Show Outcome Measure 89

90.  Secondary:   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) ]
  Show Outcome Measure 90

91.  Secondary:   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) ]
  Show Outcome Measure 91

92.  Secondary:   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) ]
  Show Outcome Measure 92

93.  Secondary:   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) ]
  Show Outcome Measure 93

94.  Secondary:   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) ]
  Show Outcome Measure 94

95.  Secondary:   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) ]
  Show Outcome Measure 95

96.  Secondary:   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) ]
  Show Outcome Measure 96

97.  Secondary:   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) ]
  Show Outcome Measure 97

98.  Secondary:   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) ]
  Show Outcome Measure 98

99.  Secondary:   Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities 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]) ]
  Show Outcome Measure 99

100.  Secondary:   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) ]
  Show Outcome Measure 100

101.  Secondary:   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) ]
  Show Outcome Measure 101

102.  Secondary:   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) ]
  Show Outcome Measure 102

103.  Secondary:   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) ]
  Show Outcome Measure 103

104.  Secondary:   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) ]
  Show Outcome Measure 104

105.  Secondary:   Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3   [ Time Frame: Baseline, Weeks 4,8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change) ]
  Show Outcome Measure 105

106.  Secondary:   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) ]
  Show Outcome Measure 106

107.  Secondary:   Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3   [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change) ]
  Show Outcome Measure 107

108.  Secondary:   Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3   [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change) ]
  Show Outcome Measure 108

109.  Secondary:   Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3   [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change) ]
  Show Outcome Measure 109

110.  Secondary:   Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3   [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change) ]
  Show Outcome Measure 110

111.  Secondary:   Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3   [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change) ]
  Show Outcome Measure 111

112.  Secondary:   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]) ]
  Show Outcome Measure 112

113.  Secondary:   Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania)   [ 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]) ]
  Show Outcome Measure 113

114.  Secondary:   Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint   [ 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]) ]
  Show Outcome Measure 114

115.  Secondary:   Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint   [ 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]) ]
  Show Outcome Measure 115

116.  Secondary:   Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase   [ 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]) ]
  Show Outcome Measure 116

117.  Secondary:   Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase   [ 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]) ]
  Show Outcome Measure 117

118.  Secondary:   Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint   [ 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]) ]
  Show Outcome Measure 118

119.  Secondary:   Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations   [ 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]) ]
  Show Outcome Measure 119

120.  Secondary:   Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase   [ 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]) ]
  Show Outcome Measure 120

121.  Secondary:   Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities   [ 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]) ]
  Show Outcome Measure 121

122.  Secondary:   Extension Phase: Adverse Events (AEs), by Maximum Intensity   [ 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]) ]
  Show Outcome Measure 122

123.  Secondary:   Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities   [ 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]) ]
  Show Outcome Measure 123

124.  Secondary:   Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities   [ 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]) ]
  Show Outcome Measure 124


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:


Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00261443     History of Changes
Other Study ID Numbers: CN138-189
Study First Received: December 1, 2005
Results First Received: January 28, 2011
Last Updated: April 8, 2011
Health Authority: United States: Food and Drug Administration