| Primary | Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set) | The YMRS is a clinician-administered scale, consisting of 11 multiple choice items, and used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-though disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward. | All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. | Posted | | Mean | Standard Error | Units on a scale | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Valproate or Lithium | Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. | | OG001 | Aripiprazole + Valproate or Lithium | Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-11.54± 0.78
- OG001-13.57± 0.78
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | | 0.058 | | Mean Difference (Final Values) | -2.04 | | | 2-Sided | 95 | -4.14 | 0.07 | | | | No | Superiority or Other | | |
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| Secondary | Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set) | Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward. | All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants. | Posted | | Mean | Standard Error | Units on a scale | | Baseline to Weeks 3, 6, 9, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Valproate or Lithium | Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. | | OG001 | Aripiprazole + Valproate or Lithium | Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12. |
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| Secondary | Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set) | Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward. | All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants. | Posted | | Mean | Standard Error | Units on a scale | | Baseline to Weeks 3, 6, 9, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Valproate or Lithium | Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. | | OG001 | Aripiprazole + Valproate or Lithium | Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12. |
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| Secondary | Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set) | Adjusted mean change. The CGI-BP is scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward. | All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants. | Posted | | Mean | Standard Error | Units on a scale | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Valproate or Lithium | Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. | | OG001 | Aripiprazole + Valproate or Lithium | Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12. |
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| Secondary | Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set) | The FAST is an interview-administered instrument used to assess the main functioning problems that patients with bipolar disorder experience. Participants are rated at Baseline, Week 3, Week 6, Week 9, and Week 12/End of Study Visit. The FAST consists of 24 items that assess impairment or disability in 6 specific areas of functioning, categorized as the subscales: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal (IP) relationships, and leisure time. All items are rated using a 4-point scale, 0=no difficulty, 1=mild difficulty, 2=moderate difficulty, and 3=severe difficulty. The global score is the sum of the scores of all items and ranges from 0 (0*24)to 96 (4*24). The higher the global score, the higher the level of impairment. function=functioning. LOCF=last observation carried forward. | All randomized participants who received at least 1 dose of study medication and who had at least 1 outcomes research evaluation after the start of study drug. n=number of evaluable participants. | Posted | | Mean | Standard Error | Units on a scale | | Baseline to Weeks 3, 6, 9, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Valproate or Lithium | Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. | | OG001 | Aripiprazole + Valproate or Lithium | |
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| Secondary | Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set) | Response on the YMRS is defined as a 50% or greater improvement from baseline in YMRS total score. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. OC=observed cases. | All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants. | Posted | | Number | | Percentage of participants | | Baseline to Weeks 3, 6, 9, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Valproate or Lithium | Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. | | OG001 | Aripiprazole + Valproate or Lithium | |
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| Secondary | Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set) | Remission is defined as a YMRS total score of 12 or less. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward. | All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants. | Posted | | Number | | Percentage of participants | | Baseline to Weeks 3,6, 9, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Valproate or Lithium | Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. | | OG001 | Aripiprazole + Valproate or Lithium | |
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| Secondary | Change From Baseline in Total Score on the Longitudinal Interval Follow-up Evaluation-Rating Impaired Functioning Tool (LIFE-RIFT)(OC Data Set and Week 12 LOCF Data Set) | Adjusted mean change. The LIFE-RIFT total score ranges from 4 to 20 and is the sum of scores of 4 items: work, interpersonal relations, satisfaction, and recreation. A negative change score signifies improvement. OC=observed cases; LOCF=last observation carried forward. | All randomized participants who received at least 1 dose of study medication and had at least 1 outcome research evaluation after the start of study drug. n=number of evaluable participants. | Posted | | Mean | Standard Error | Units on a scale | | Baseline to Weeks 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Valproate or Lithium | Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. | | OG001 | Aripiprazole + Valproate or Lithium | Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12. |
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| Secondary | Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set) | Adjusted Mean Scores. The PGI-I is a self-administered 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. OC=observed cases. | All randomized participants who received at least 1 dose of study medication and who had at least 1 outcomes research evaluation after the start of study drug. n=number of evaluable participants. | Posted | | Mean | Standard Error | Units on a scale | | Baseline to Weeks 3, 6, 9, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Valproate or Lithium | Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. | | OG001 | Aripiprazole + Valproate or Lithium | Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12. |
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| Secondary | Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set) | Adjusted mean change.OC=observed cases; LOCF=last observation carried forward. | All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants. | Posted | | Mean | Standard Error | Kilograms | | Baseline to Weeks 3, 6, 9, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Valproate or Lithium | Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. | | OG001 | Aripiprazole + Valproate or Lithium | Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12. |
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| Secondary | Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set) | Relevant weight gain=7% or greater increase in weight; relevant weight loss=7% or greater decrease in weight. LOCF=last observation carried forward. | All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants. | Posted | | Number | | Percentage of participants | | Baseline to Weeks 3, 6, 9, and12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Valproate or Lithium | Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. | | OG001 | Aripiprazole + Valproate or Lithium | Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12. |
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| Secondary | Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set) | BMI=Weight in kilograms /(Height in meters^2). LOCF=last observation carried forward. | All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants. | Posted | | Median | Full Range | kg/m^2 | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Valproate or Lithium | Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. | | OG001 | Aripiprazole + Valproate or Lithium | Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12. |
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