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
Phase 4
Completed
NCT00277212
| Condition | Bipolar Disorder |
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| Phase | Phase 4 |
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| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| Status | Completed |
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| Enrollment | 1,169 participants |
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| Interventions | Lamotrigine + Aripiprazole, Lamotrigine + Placebo |
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| Start date | Dec 1, 2005 |
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| Completion date | Jul 1, 2009 |
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| Results posted | Oct 20, 2010 |
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Summary
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
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 · Proportion of Participants
| Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | 1.00 Proportion of Participants |
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| Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | 1.00 Proportion of Participants |
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| Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | 0.98 Proportion of Participants |
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| Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | 0.98 Proportion of Participants |
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| Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | 0.97 Proportion of Participants |
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| Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole | 0.96 Proportion of Participants |
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| p-value | 0.058 |
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| Cox Proportional Hazard | 0.552 (95% CI 0.296–1.030) |
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Open in BENITIONS
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