At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 748 enrolled
Drug / intervention
Aripiprazoledrug
Likely dose
Aripiprazole 400mgfrom 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.
A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Oct 19, 2012·Updated Sep 21, 2018
In Brief
A Phase 3 clinical trial evaluating Aripiprazole for Bipolar I. Completed, enrolled 748 participants across 142 sites in 10 countries.
Detailed Summary
This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects not participating in Trial 31-08-250.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I
CountriesCanada, France, Hungary, Japan, Malaysia, Poland, Romania, South Korea, Taiwan, United States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartNov 2012
Primary CompletionNov 2016
Study CompletionDec 2016
TodayJul 2026
First PostedOct 19, 2012
Enrollment StartNov 1, 2012
Primary CompletionNov 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 13.7 years ago
Interventions
Aripiprazoledrug
400mg or 300mg, intramuscular injections every 4 weeks.