Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
3期
已完成
NCT00706654
| 适应症 | Schizophrenia |
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| 分期 | 3期 |
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| 申办方 | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| 状态 | 已完成 |
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| 受试者人数 | 937 人 |
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| 干预（药物） | Aripiprazole depot 300 or 400 mg, Aripiprazole 10-30 mg orally, Aripiprazole depot 25 or 50 mg, Placebo depot, Placebo tablets |
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| 开始日期 | 2008年9月1日 |
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| 完成日期 | 2012年8月1日 |
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| 结果公布日 | 2013年8月14日 |
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摘要
The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.
Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26
Baseline to Week 26 · Percentage of patients
| Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase | 7.12 Percentage of patients |
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| Aripiprazole 10-30 mg Orally - Depot Maintenance Phase | 7.76 Percentage of patients |
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| Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase | 21.80 Percentage of patients |
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| p-value | 0.7871 |
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| Mean Difference (Final Values) | -0.64 (95% CI -5.26–3.99) |
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