Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia - Full Text View

Sponsored by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:	NCT00705783

Purpose

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
Schizophrenia	Drug: Intramuscular (IM) Depot Aripiprazole Formulation Drug: Intramuscular (IM) Depot Placebo	Phase III

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

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

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

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 ]

Secondary Outcome Measures:

Mean change from baseline to endpoint in PANSS Total Score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Mean change from baseline to endpoint in the PSP Scale [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Mean change from baseline to endpoint in CGI-S [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

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
1: Active Comparator Active Comparator: Treatment of Aripiprazole IM Depot	Drug: Intramuscular (IM) Depot Aripiprazole Formulation Intramuscular (IM) Depot Aripiprazole Formulation 400 mg or 300 mg, once a month injection
2: Placebo Comparator Placebo Comparator: Treatment of IM Depot Placebo	Drug: Intramuscular (IM) Depot Placebo Intramuscular (IM) Depot Placebo 400 mg or 300 mg, once a month injection

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as require by IRB/IEC), prior to the initiation of any protocol-required procedures.
Male and female subjects 18 to 60 years of age, inclusive, at time of informed consent.
Subjects with a current diagnosis of schizophrenia as defined by DSM-IV-TR criteria and a history of the illness for at least three years prior to screening.
Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication.
Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcomes measures, and who can be reliably rated on assessment scales.

Exclusion Criteria:

Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history.
Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
Subjects who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine.
Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
Subjects with a history of hypersensitivity to antipsychotic agents.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705783

Contacts

Contact: Clinical Contact Line

1-866-670-3668

Locations

United States, California
Synergy Clinical Research Center	Recruiting
National City, California, United States

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

Principal Investigator:

Mohammed Bari, MD

Synergy Clinical Research Center

More Information

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
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

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Aripiprazole
Intramuscular (IM) Depot
Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Aripiprazole
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009