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Sponsored by: |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
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Information provided by: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
ClinicalTrials.gov Identifier: | NCT00705783 |
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.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: Intramuscular (IM) Depot Aripiprazole Formulation Drug: Intramuscular (IM) Depot Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 1000 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | August 2012 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Active Comparator: Treatment of Aripiprazole IM Depot
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Drug: Intramuscular (IM) Depot Aripiprazole Formulation
Intramuscular (IM) Depot Aripiprazole Formulation 400 mg or 300 mg, once a month injection
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2: Placebo Comparator
Placebo Comparator: Treatment of IM Depot Placebo
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Drug: Intramuscular (IM) Depot Placebo
Intramuscular (IM) Depot Placebo 400 mg or 300 mg, once a month injection
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Clinical Contact Line | 1-866-670-3668 |
United States, California | |
Synergy Clinical Research Center | Recruiting |
National City, California, United States |
Principal Investigator: | Mohammed Bari, MD | Synergy Clinical Research Center |
Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. ( Senior Manager, Global Clinical Development ) |
Study ID Numbers: | 31-07-246 |
Study First Received: | June 24, 2008 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00705783 History of Changes |
Health Authority: | United States: Food and Drug Administration; India: Drugs Controller General of India; Taiwan: Department of Health; Romania: Ministry of Public Health; Slovakia: State Institute for Drug Control; Peru: Ministry of Health; Malaysia: Ministry of Health; Bulgaria: Ministry of Health; Ukraine: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Philippines: Department of Health; Lithuania: States Medicines Control Agency - Ministry of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Serbia: Agency for Drugs and Medicinal Devices; Mexico: Ministry of Health |
Aripiprazole Intramuscular (IM) Depot Schizophrenia |
Schizophrenia Tranquilizing Agents Mental Disorders Psychotropic Drugs Central Nervous System Depressants |
Psychotic Disorders Aripiprazole Antipsychotic Agents Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Tranquilizing Agents Mental Disorders Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Aripiprazole Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions Schizophrenia and Disorders with Psychotic Features |