Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Phase 3
Completed
NCT00706654
| Condition | Schizophrenia |
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| Phase | Phase 3 |
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| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| Status | Completed |
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| Enrollment | 937 participants |
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| Interventions | 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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| Start date | Sep 1, 2008 |
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| Completion date | Aug 1, 2012 |
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| Results posted | Aug 14, 2013 |
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Summary
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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Open in BENITIONS
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