At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 709 enrolled
Drug / intervention
Aripiprazoledrug
Likely dose
Aripiprazole 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted May 25, 2010·Updated Jan 6, 2020
In Brief
A Phase 3 clinical trial evaluating Aripiprazole for Schizophrenia. Completed, enrolled 709 participants across 157 sites in 24 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesArgentina, 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, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartJun 2010
Primary CompletionDec 2018
TodayJul 2026
First PostedMay 25, 2010
Enrollment StartJun 24, 2010
Primary CompletionDec 6, 2018
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 16.1 years ago
Interventions
Aripiprazoledrug
Aripiprazole IM depot - 300 mg or 400 mg