Trial · NCT00665366
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
NCT00665366, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2013-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder. Trials, record NCT00665366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00665366
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
- NCT number
- NCT00665366
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 493 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Bipolar Disorder Mania
- Interventions
- Aripiprazole, Placebo, Lithium, Valproate
- First posted
- 2008-04-23
- Last updated
- 2013-12-02
- Other registries' IDs
- eudract:2007-005959-42
- Results first posted
- 2013-02-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set) | Baseline to Week 12 | 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. |
| Secondary | Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set) | Baseline to Weeks 3, 6, 9, and 12 | 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. |
| Secondary | Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set) | Baseline to Weeks 3, 6, 9, and 12 | 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. |
| 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) | Baseline to Week 12 | 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. |
| Secondary | Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set) | Baseline to Weeks 3, 6, 9, and 12 | 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. |
| Secondary | Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set) | Baseline to Weeks 3, 6, 9, and 12 | 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. |
| Secondary | Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set) | Baseline to Weeks 3,6, 9, and 12 | 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. |
| 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) | Baseline to Weeks 6 and 12 | 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. |
| Secondary | Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set) | Baseline to Weeks 3, 6, 9, and 12 | 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. |
| Secondary | Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set) | Baseline to Weeks 3, 6, 9, and 12 | Adjusted mean change.OC=observed cases; LOCF=last observation carried forward. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set) | Baseline to Week 12 | 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. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set) | Baseline to Weeks 3, 6, 9, and 12 | 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. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set) | Baseline to Weeks 3, 6, 9, and 12 | 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. | Units on a scale | MEAN |
| 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) | Baseline to Week 12 | 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. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set) | Baseline to Weeks 3, 6, 9, and 12 | 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. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set) | Baseline to Weeks 3, 6, 9, and 12 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set) | Baseline to Weeks 3,6, 9, and 12 | 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. | Percentage of participants | NUMBER |
| 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) | Baseline to Weeks 6 and 12 | 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. | Units on a scale | MEAN |
| SECONDARY | Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set) | Baseline to Weeks 3, 6, 9, and 12 | 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. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set) | Baseline to Weeks 3, 6, 9, and 12 | All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants. | Kilograms | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group122
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set) | Placebo + Valproate or Lithium | -11.54 | Standard Error 0.78 | Units on a scale | |
| Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set) | Aripiprazole + Valproate or Lithium | -13.57 | Standard Error 0.78 | Units on a scale | |
| Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set) | Placebo + Valproate or Lithium | Week 3 (n=183, 174) | -0.97 | Standard Error 0.08 | Units on a scale |
| Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set) | Aripiprazole + Valproate or Lithium | Week 3 (n=183, 174) | -0.93 | Standard Error 0.08 | Units on a scale |
| Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set) | Placebo + Valproate or Lithium | Week 6 (n=186, 176) | -1.35 | Standard Error 0.09 | Units on a scale |
| Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set) | Aripiprazole + Valproate or Lithium | Week 6 (n=186, 176) | -1.46 | Standard Error 0.10 | Units on a scale |
| Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set) | Placebo + Valproate or Lithium | Week 9 (n=186, 176) | -1.55 | Standard Error 0.10 | Units on a scale |
| Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set) | Aripiprazole + Valproate or Lithium | Week 9 (n=186, 176) | -1.83 | Standard Error 0.11 | Units on a scale |
| Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set) | Placebo + Valproate or Lithium | Week 12 (n=186, 176) | -1.78 | Standard Error 0.11 | Units on a scale |
| Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set) | Aripiprazole + Valproate or Lithium | Week 12 (n=186, 176) | -2.07 | Standard Error 0.11 | Units on a scale |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo + Valproate or Lithium | 189 | |
| Overall Study | STARTED | Aripiprazole + Valproate or Lithium | 181 | |
| Overall Study | COMPLETED | Placebo + Valproate or Lithium | 131 | |
| Overall Study | COMPLETED | Aripiprazole + Valproate or Lithium | 122 | |
| Overall Study | NOT COMPLETED | Placebo + Valproate or Lithium | 58 | |
| Overall Study | NOT COMPLETED | Aripiprazole + Valproate or Lithium | 59 |
Source ClinicalTrials.gov
Adverse events56
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 | Insomnia | Psychiatric disorders | Aripiprazole | 10 | 180 | |
| other | Insomnia | Psychiatric disorders | Placebo | 10 | 189 | |
| other | Depression | Psychiatric disorders | Aripiprazole | 14 | 180 | |
| other | Depression | Psychiatric disorders | Placebo | 5 | 189 | |
| other | Nausea | Gastrointestinal disorders | Aripiprazole | 10 | 180 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 189 | |
| other | Akathisia | Nervous system disorders | Aripiprazole | 20 | 180 | |
| other | Akathisia | Nervous system disorders | Placebo | 4 | 189 | |
| other | Headache | Nervous system disorders | Aripiprazole | 5 | 180 | |
| other | Headache | Nervous system disorders | Placebo | 10 | 189 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aripiprazole | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Aripiprazole | 45 | 180 |
| Total, other adverse events | Placebo | 29 | 189 |
| Total, serious adverse events | Aripiprazole | 11 | 180 |
| Total, serious adverse events | Placebo | 17 | 189 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Aripiprazole vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00665366
GET https://conductscience.org/api/trials/v1/NCT00665366/results?page=2