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Tracking Information | |||||
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First Received Date † | June 24, 2008 | ||||
Last Updated Date | December 31, 2008 | ||||
Start Date † | July 2008 | ||||
Current Primary Outcome Measures † |
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 † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00705783 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia | ||||
Official Title † | 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. |
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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. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Schizophrenia | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 1000 | ||||
Estimated Completion Date | August 2012 | ||||
Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 60 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00705783 | ||||
Responsible Party | Senior Manager, Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc. | ||||
Secondary IDs †† | |||||
Study Sponsor † | Otsuka Pharmaceutical Development & Commercialization, Inc. | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Otsuka Pharmaceutical Development & Commercialization, Inc. | ||||
Verification Date | December 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |