Tracking Information
Start Date ICMJE | July 2008 |
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Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 31, 2008) | The primary efficacy endpoint of this study is time to exacerbation of psychotic symptoms/impending relapse, in schizophrenic patients who have maintained stability on aripiprazole IM depot for at least 12 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: June 25, 2008) | The primary objective of the study is to evaluate the efficacy of aripiprazole IM depot compared with placebo IM depot, as measured by time to exacerbation of psychotic symptoms/impending relapse. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ] |
Change History | Complete list of historical versions of study NCT00705783 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 31, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia |
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Official Title ICMJE | A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia |
Brief Summary | The purpose of the trial is to evaluate the efficacy, safety, and tolerability of an intramuscular depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia. The trial is designed into four treatment phases. Phase 1 is designed to allow for a subject to be converted from the current antipsychotic treatment to oral aripiprazole monotherapy. During Phase 2 the subject will be stabilized on oral aripiprazole monotherapy. Once the subject is stabilized in Phase 2 they will enter Phase 3, the single-blind IM depot aripiprazole stabilization phase. The goal of the phase is to stabilize the subject on the IM depot aripiprazole formulation. When the subject is stabilized, they would be eligible to be randomized into the double-blind IM depot maintenance phase, Phase 4. During Phase 4, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for 52 weeks. |
Detailed Description | This will be a randomized, double-blind, placebo-controlled study consisting of a screening phase and four treatment phases. Eligibility will be determined during a screening phase of 2 to 42 days. Subjects currently receiving oral treatment with an antipsychotic other than aripiprazole will enter Phase 1. During Phase 1 (oral conversion), subjects will be cross-titrated during weekly visits from other antipsychotics to oral aripiprazole monotherapy over a minimum of 4 weeks and a maximum of 6 weeks. During Phase 2 (that will be a minimum of 4 weeks and a maximum of 12 weeks in duration), subjects will be assessed bi-weekly and stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. After stability criteria are met at Phase 2, subjects will enter the single-blind aripiprazole IM depot stabilization phase, Phase 3. At Phase 3 subjects will need to be stabilized on aripiprazole IM depot for 6 consecutive visits. Once the subjects meet the stability criteria, they are eligible to be randomized into the double-blind phase, Phase 4. Subjects will be randomized with a 2:1 ratio (aripiprazole IM depot vs placebo IM depot). During Phase 4, subjects will be assessed for impending relapse/exacerbation of psychotic symptoms. If a subject is identified with impending relapse/exacerbation of psychotic symptoms, they will be withdrawn from the trial and given the opportunity to enroll into an open-label aripiprazole IM depot trial, 31-08-248. Alternatively, subjects that complete Phase 4 (up to and including week-52) will have the option to enroll into an open-label aripiprazole IM depot trial, 31-08-248. |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Condition ICMJE | Schizophrenia |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 1000 | ||||
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Estimated Completion Date | August 2012 | ||||
Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 60 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Bulgaria, India, Malaysia, Mexico, Peru, Philippines, Romania, Russian Federation, Serbia, Slovakia, Taiwan |
Administrative Information
NCT ID ICMJE | NCT00705783 |
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Responsible Party | Juan Torres, Project Director, Covance, Inc. |
Study ID Numbers ICMJE | 31-07-246 |
Study Sponsor ICMJE | Otsuka Pharmaceutical Development & Commercialization, Inc. |
Collaborators ICMJE | Covance |
Investigators ICMJE | |
Information Provided By | Otsuka Pharmaceutical Development & Commercialization, Inc. |