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
第4相
完了
NCT00277212
| 対象疾患 | Bipolar Disorder |
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| 相 | 第4相 |
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| スポンサー | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| ステータス | 完了 |
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| 参加者数 | 1,169 名 |
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| 介入（薬剤） | Lamotrigine + Aripiprazole, Lamotrigine + Placebo |
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| 開始日 | 2005年12月1日 |
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| 完了日 | 2009年7月1日 |
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| 結果公開日 | 2010年10月20日 |
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概要
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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