An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia

• Status: Completed
• Trial end date: 2018-12-06
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study was to continue to provide aripiprazole intramuscular (IM) depot treatment (400 milligrams [mg] or 300 mg) to participants with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248. In addition, the secondary objective was to collect additional long-term safety data on aripiprazole IM depot treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• Participants with a current diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria, who completed the open-label extension Study 248 (completed Study 248 study completion visit, Week 52).

• Participants who, in the investigator's judgment, may benefit from continued participation in an aripiprazole IM Depot study.

• The baseline visit for Study 270 (which is the Week 52 visit of Study 248) and the first injection for Study 270 must occur within 4 weeks (which was defined as 28 [-2/+10] days) of the last injection in Study 248.

• Participants who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by an Independent Review Board/Independent Ethics Committee (IRB/IEC), prior to the initiation of any protocol-required procedures.

• Participants able to understand the nature of the study and follow protocol requirements and who can read and understand the written word in order to complete patient-reported outcomes measures.

• Outpatient status.

Exclusion Criteria:

• Participants 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.

• Participants with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.

• Participants who currently meet DSM-IV-TR criteria for substance dependence, including alcohol and benzodiazepines, but excluding caffeine and nicotine.

• Participants with a significant risk of violent behavior or a significant risk of committing suicide based on the investigator's judgment.

• Participants who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.

• Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.

• Electroconvulsive therapy within 180 days prior to entry.

• Any participant who requires or may need any other antipsychotic medications during the course of the study.

• Aripiprazole IM Depot (including generic formulation) is commercially available in the participant's country.

• Other protocol specific inclusion/exclusion criteria may apply.