Trial · NCT00261443
A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania
NCT00261443, Phase 4, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2011-04-27
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ConductScience Library. A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania. Trials, record NCT00261443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00261443
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania
- NCT number
- NCT00261443
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,270 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Bipolar Disorder
- Interventions
- Lithium or Valproate with placebo (PBO), Lithium or Valproate with Aripiprazole
- First posted
- 2005-12-05
- Last updated
- 2023-04-18
- Results first posted
- 2011-04-27
Source ClinicalTrials.gov
Registered outcomes124
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | 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]) | 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 | 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 | Baseline (end of Phase 2), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | 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. |
| Secondary | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of 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. |
| Secondary | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of 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. |
| Secondary | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | 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) | 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). |
| Secondary | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | 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]) | 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). |
| 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 | 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) | 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. |
| Secondary | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | 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]) | 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. |
| Secondary | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | 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) | 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. |
| Secondary | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | 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]) | 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. |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 registered outcomesOutcomes124
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | 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]) | Randomized Sample; n=number of participants at risk at each time point | proportion of participants | NUMBER |
| 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 | Baseline (end of Phase 2), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | LOCF data set, phase 3 efficacy sample; n=number of participants evaluated at given time point | units on a scale | MEAN |
| SECONDARY | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3 | Randomized sample, n=number of participants at risk at given time point | proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3 | Randomized sample, n=number of participants at risk at given time point | proportion of participants | NUMBER |
| SECONDARY | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | 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) | Observed Cases (OC) data set; n=number of participants with measurement at given time point. | units on a scale | MEAN |
| SECONDARY | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | 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]) | LOCF data set, phase 3 efficacy sample; n=number of participants with measurement at time point | units on a scale | MEAN |
| 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 | 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) | Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point | units on a scale | MEAN |
| SECONDARY | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | 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]) | LOCF data set, phase 3 efficacy sample; N=number of participants evaluated at time point; 4 participants in the Week 4 placebo group were not evaluated. | units on a scale | MEAN |
| SECONDARY | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | 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) | Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point | units on a scale | MEAN |
| SECONDARY | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | 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]) | LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated. | units on a scale | MEAN |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 outcomesResults by group1,642
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Placebo | Proportion at Week 0 (n=169, 168) | 1.00 | proportion of participants | |
| Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Aripiprazole | Proportion at Week 0 (n=169, 168) | 1.00 | proportion of participants | |
| Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Placebo | Proportion at Week 4 (n=153, 148) | 0.95 | proportion of participants | |
| Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Aripiprazole | Proportion at Week 4 (n=153, 148) | 0.96 | proportion of participants | |
| Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Placebo | Proportion at Week 8 (n=148, 139) | 0.93 | proportion of participants | |
| Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Aripiprazole | Proportion at Week 8 (n=148, 139) | 0.94 | proportion of participants | |
| Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Placebo | Proportion at Week 12 (n=142, 133) | 0.90 | proportion of participants | |
| Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Aripiprazole | Proportion at Week 12 (n=142, 133) | 0.93 | proportion of participants | |
| Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Placebo | Proportion at Week 16 (n=131, 130) | 0.87 | proportion of participants | |
| Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Aripiprazole | Proportion at Week 16 (n=131, 130) | 0.92 | proportion of participants |
1 to 10 of 1,642Source ClinicalTrials.gov
See all 1,642 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 1: Confirmation of Partial Nonresponse | STARTED | Pre-Randomized Participants | 1,270 | |
| 1: Confirmation of Partial Nonresponse | STARTED | Placebo | 0 | |
| 1: Confirmation of Partial Nonresponse | STARTED | Aripiprazole | 0 | |
| 1: Confirmation of Partial Nonresponse | COMPLETED | Pre-Randomized Participants | 686 | |
| 1: Confirmation of Partial Nonresponse | COMPLETED | Placebo | 0 | |
| 1: Confirmation of Partial Nonresponse | COMPLETED | Aripiprazole | 0 | |
| 1: Confirmation of Partial Nonresponse | NOT COMPLETED | Pre-Randomized Participants | 584 | |
| 1: Confirmation of Partial Nonresponse | NOT COMPLETED | Placebo | 0 | |
| 1: Confirmation of Partial Nonresponse | NOT COMPLETED | Aripiprazole | 0 | |
| 2: Stability & Maintenance of Stability | STARTED | Pre-Randomized Participants | 686 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events230
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | WEIGHT INCREASED | Investigations | Single-Blind Aripiprazole | 28 | 682 | |
| other | WEIGHT INCREASED | Investigations | Double-Blind Placebo | 11 | 166 | |
| other | WEIGHT INCREASED | Investigations | Double-Blind Aripiprazole | 15 | 167 | |
| other | WEIGHT INCREASED | Investigations | Extension Phase Placebo | 0 | 19 | |
| other | WEIGHT INCREASED | Investigations | Extension Phase Aripiprazole | 1 | 23 | |
| other | INSOMNIA | Psychiatric disorders | Single-Blind Aripiprazole | 61 | 682 | |
| other | INSOMNIA | Psychiatric disorders | Double-Blind Placebo | 16 | 166 | |
| other | INSOMNIA | Psychiatric disorders | Double-Blind Aripiprazole | 9 | 167 | |
| other | INSOMNIA | Psychiatric disorders | Extension Phase Placebo | 0 | 19 | |
| other | INSOMNIA | Psychiatric disorders | Extension Phase Aripiprazole | 2 | 23 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single-Blind Aripiprazole | ||
| Total, all-cause mortality | Double-Blind Placebo | ||
| Total, all-cause mortality | Double-Blind Aripiprazole | ||
| Total, all-cause mortality | Extension Phase Placebo | ||
| Total, all-cause mortality | Extension Phase Aripiprazole | ||
| Total, other adverse events | Single-Blind Aripiprazole | 402 | 682 |
| Total, other adverse events | Double-Blind Placebo | 61 | 166 |
| Total, other adverse events | Double-Blind Aripiprazole | 68 | 167 |
| Total, other adverse events | Extension Phase Placebo | 5 | 19 |
| Total, other adverse events | Extension Phase Aripiprazole | 6 | 23 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21443567 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00261443
GET https://conductscience.org/api/trials/v1/NCT00261443/registered?page=2