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

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01129882

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

709

Starts

2010-06-24

Expected to finish

2018-12-06

Last updated by the study team

2020-01-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Garden Grove, California, United States
• Study site — Glendale, California, United States
• Study site — Glendale, California, United States
• Study site — Imperial, California, United States
• Study site — Los Angeles, California, United States
• Study site — National City, California, United States
• Study site — National City, California, United States
• Study site — Orange, California, United States
• Study site — Pasadena, California, United States
• Study site — Pico Rivera, California, United States
• Study site — Pico Rivera, California, United States
• Study site — San Bernardino, California, United States
• Study site — San Diego, California, United States
• Study site — Sherman Oaks, California, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Bradenton, Florida, United States
• Study site — Doral, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Homestead, Florida, United States
• Study site — Orange City, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Bellevue, California, United States

Full record on ClinicalTrials.gov

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