NCT01129882

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 709 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was an open-label study that enrolled participants with schizophrenia who had completed the 52-week, open-label safety and tolerability Study 31-08-248 and continued to provide aripiprazole IM depot treatment. Participants received this treatment until aripiprazole IM Depot was commercially available in any dosage (including generic formulations) in the country where the study was being conducted or the commercial availability of aripiprazole IM Depot was terminated by the sponsor, or until the study completion date of 06 Dec 2018 was reached. Eligible participants entered this study at the end of treatment visit (Week 52) of Study 31-08-248. Participants continued to receive aripiprazole IM depot every month (study months were every 4 weeks, which were defined as 28 \[-2/+10\] days) as a continuation of their previous monthly dose in Study 31-08-248.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Aripiprazole	Aripiprazole IM depot - 300 mg or 400 mg

Timeline

• Start date: 2010-06-24
• Primary completion: 2018-12-06
• Completion: 2018-12-06
• First posted: 2010-05-25
• Last updated: 2020-01-06
• Results posted: 2020-01-06

Locations

157 sites across 24 countries: United States, Argentina, Australia, Bulgaria, Chile, Croatia, Estonia, Finland, Hungary, India, Malaysia, Mexico, Philippines, Poland, Puerto Rico, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand

Regulatory

• FDA-regulated drug study