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Sponsors and Collaborators: |
Otsuka Pharmaceutical Development & Commercialization, Inc. Covance Inc. |
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Information provided by: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
ClinicalTrials.gov Identifier: | NCT00706654 |
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 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 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 38 weeks.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: Intramuscular (IM) Depot Aripiprazole Formulation Drug: Oral Aripiprazole 10 mg - 30 mg, daily Drug: Intramuscular (IM) Depot Aripiprazole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A 38-Week, Multicenter, Randomized, Double-Blind, Active-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: | September 2008 |
Estimated Primary Completion Date: | September 2011 (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
Intramuscular (IM) Depot Aripiprazole 400 mg or 300 mg, once a month injection
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2: Active Comparator
Active Comparator: Oral Aripiprazole
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Drug: Oral Aripiprazole 10 mg - 30 mg, daily
Oral Aripiprazole 10 mg - 30 mg, daily
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3: Active Comparator
Active Comparator: Treatment of Aripiprazole IM Depot
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Drug: Intramuscular (IM) Depot Aripiprazole Formulation
Intramuscular (IM) Depot Aripiprazole Formulation 50 mg or 25 mg, once a month injection
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This will be a randomized, double-blind, active-controlled study consisting of a screening phase and three 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 8 weeks and a maximum of 28 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 are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. Subjects will be randomized with a 2:2:1 (aripiprazole IM depot 400 mg, oral aripiprazole, aripiprazole IM depot 50 mg). During Phase 3 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 3 (up to and including week-38) 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 | |
Collaborative Neuroscience Network, Inc. | Recruiting |
Garden Grove, California, United States |
Principal Investigator: | David Walling, PhD | Collaborative Neuroscience Network, Inc. |
Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. ( Senior Manager, Global Clinical Development ) |
Study ID Numbers: | 31-07-247 |
Study First Received: | June 25, 2008 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00706654 |
Health Authority: | United States: Food and Drug Administration; Austria: Federal Office of Safety in Health Care; Belgium: Federal Agency for Medicinal Products and Health Products; Bulgaria: Ministry of Health; Chile: Comisión Nacional de Investigación Científica y Tecnológica; China : State Food and Drug Aministration; Croatia: Ministry of Health and Social Care; Czech Republic: State Institute of Drug Control; Estonia: The State Agency of Medicine; France: Ministry of Health; Germany: Federal Institute of Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Israel: Ministry of Health; Italy: Ministry of Health; Poland: Ministry of Health; South Africa: Medicines Control Council; South Korea: Korea Food and Drug Administration (KFDA); Spain: Spanish Agency of Medicines; Thailand: Food and Drug Administration |
Aripiprazole Intramuscular (IM) Depot Schizophrenia |
Schizophrenia Mental Disorders Psychotic Disorders Aripiprazole Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |