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
Фаза 4
Завершено
NCT00277212
| Заболевание | Bipolar Disorder |
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| Фаза | Фаза 4 |
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| Спонсор | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| Статус | Завершено |
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| Участники | 1,169 участн. |
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| Вмешательство | Lamotrigine + Aripiprazole, Lamotrigine + Placebo |
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| Дата начала | 1.12.2005 |
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| Дата завершения | 1.07.2009 |
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| Публикация результатов | 20.10.2010 |
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Кратко
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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