Trial · NCT00277212
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
NCT00277212, Phase 4, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2010-10-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode. Trials, record NCT00277212. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00277212
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
- NCT number
- NCT00277212
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,169 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Bipolar Disorder
- Interventions
- Lamotrigine + Aripiprazole, Lamotrigine + Placebo
- First posted
- 2006-01-16
- Last updated
- 2026-05-13
- Results first posted
- 2010-10-20
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) | Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate). |
| Secondary | Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2 | Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate). |
| Secondary | Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2) | Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate). |
| Secondary | Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2) | Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Proportion of Participants without Discontinuation Through Week 52(Kaplan-Meier's estimated survival rate). |
| Secondary | Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs | Throughout Phase 2 (up to 52 weeks) | AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. |
| Secondary | Adjusted Mean Change From Baseline in Body Weight, Phase 2 | Baseline, Week 52 | Adjusted for index mood episode and baseline assessment |
| Secondary | Number of Participants Showing Clinically Relevant Weight Loss by Study Week | Weeks 12, 24, 36, 52 | Weight Loss of at least a 7% decrease from Baseline. |
| Secondary | Number of Participants Showing Clinically Relevant Weight Gain by Study Week | Weeks 12, 24, 36, 52 | Weight gain of at least a 7% increase from Baseline. |
| Secondary | Adjusted Mean Change From Baseline in BMI by Study Week | Baseline, Weeks 12, 24, 36, 52 | Adjusted for index mood episode and baseline assessment. |
| Secondary | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment | Throughout the study, up to Week 52 | Abbreviations and further description used in table: Sinus tachycardia, ≥120 beats per minute (bpm) and ↑ ≥15 bpm \& no current diagnosis of supraventricular or ventricular tachycardia/atrial fibrillation (AF)/atrial flutter/ other rhythm abnormality. Sinus bradycardia, ≤ 50 bpm and ↓ 15 bpm \& no current diagnosis of AF/atrial flutter/other rhythm abnormality. Supraventricular premature beat (SPB), Ventricular premature beat (VPB), Atroventricular (A-V). Other intraventricular block, QRS ≥0.12 sec and ↑ ≥0.02 sec \& no current diagnosis of left or right bundle branch block. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) | Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point. | Proportion of Participants | NUMBER |
| SECONDARY | Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2 | Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point. | Proportion of Participants | NUMBER |
| SECONDARY | Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2) | Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point. | Proportion of Participants | NUMBER |
| SECONDARY | Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2) | Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point. | Proportion of Participants | NUMBER |
| SECONDARY | Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs | Throughout Phase 2 (up to 52 weeks) | The Phase 2 Safety Sample comprises all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form. | participants | NUMBER |
| SECONDARY | Adjusted Mean Change From Baseline in Body Weight, Phase 2 | Baseline, Week 52 | Participants from the phase 2 Safety Sample who had body weight evaluation at baseline and week 52 LOCF. | kg | MEAN |
| SECONDARY | Number of Participants Showing Clinically Relevant Weight Loss by Study Week | Weeks 12, 24, 36, 52 | Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point. | Participants | NUMBER |
| SECONDARY | Number of Participants Showing Clinically Relevant Weight Gain by Study Week | Weeks 12, 24, 36, 52 | Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point. | Participants | NUMBER |
| SECONDARY | Adjusted Mean Change From Baseline in BMI by Study Week | Baseline, Weeks 12, 24, 36, 52 | Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point. | kg/m2 | MEAN |
| SECONDARY | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment | Throughout the study, up to Week 52 | Participants with ECG evaluation from the phase 2 Safety Sample (all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form.) | particiapnts | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group415
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 Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | Week 0 (n=173, n=178) | 1.00 | Proportion of Participants | |
| Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | Week 0 (n=173, n=178) | 1.00 | Proportion of Participants | |
| Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | Week 2 (n=162, n=172) | 0.98 | Proportion of Participants | |
| Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | Week 2 (n=162, n=172) | 0.98 | Proportion of Participants | |
| Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | Week 4 (n=154, n=159) | 0.97 | Proportion of Participants | |
| Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | Week 4 (n=154, n=159) | 0.96 | Proportion of Participants | |
| Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | Week 6 (n=142, n=147) | 0.95 | Proportion of Participants | |
| Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | Week 6 (n=142, n=147) | 0.93 | Proportion of Participants | |
| Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | Week 8 (n=135, n=135) | 0.93 | Proportion of Participants | |
| Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | Week 8 (n=135, n=135) | 0.90 | Proportion of Participants |
1 to 10 of 415Source ClinicalTrials.gov
See all 415 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 - Single-Blind Treatment | STARTED | Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole | 787 | |
| Phase 1 - Single-Blind Treatment | STARTED | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | 0 | |
| Phase 1 - Single-Blind Treatment | STARTED | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | 0 | |
| Phase 1 - Single-Blind Treatment | Phase 1 Safety Sample | Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole | 787 | |
| Phase 1 - Single-Blind Treatment | Phase 1 Safety Sample | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | 0 | |
| Phase 1 - Single-Blind Treatment | Phase 1 Safety Sample | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | 0 | |
| Phase 1 - Single-Blind Treatment | Phase 1 Efficacy Sample | Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole | 756 | |
| Phase 1 - Single-Blind Treatment | Phase 1 Efficacy Sample | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | 0 | |
| Phase 1 - Single-Blind Treatment | Phase 1 Efficacy Sample | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | 0 | |
| Phase 1 - Single-Blind Treatment | COMPLETED | Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole | 352 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events156
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 | ANXIETY | Psychiatric disorders | Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole | 73 | 787 | |
| other | ANXIETY | Psychiatric disorders | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | 6 | 165 | |
| other | ANXIETY | Psychiatric disorders | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | 13 | 176 | |
| other | INSOMNIA | Psychiatric disorders | Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole | 138 | 787 | |
| other | INSOMNIA | Psychiatric disorders | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | 19 | 165 | |
| other | INSOMNIA | Psychiatric disorders | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | 13 | 176 | |
| other | AGITATION | Psychiatric disorders | Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole | 65 | 787 | |
| other | AGITATION | Psychiatric disorders | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | 8 | 165 | |
| other | AGITATION | Psychiatric disorders | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | 11 | 176 | |
| other | RESTLESSNESS | Psychiatric disorders | Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole | 55 | 787 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole | ||
| Total, all-cause mortality | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | ||
| Total, all-cause mortality | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | ||
| Total, other adverse events | Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole | 545 | 787 |
| Total, other adverse events | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | 61 | 165 |
| Total, other adverse events | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | 74 | 176 |
| Total, serious adverse events | Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole | 32 | 787 |
| Total, serious adverse events | Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | 9 | 165 |
| Total, serious adverse events | Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | 5 | 176 |
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 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/NCT00277212
GET https://conductscience.org/api/trials/v1/NCT00277212/results?page=2