At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 340 enrolled
Drug / intervention
Aripiprazole IM Depot +1 moredrug
Likely dose
Not stated in 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 12-week, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Aug 13, 2012·Updated Feb 16, 2015
In Brief
A Phase 3 clinical trial evaluating Aripiprazole IM Depot and Placebo for Schizophrenia. Completed, enrolled 340 participants across 49 sites in 3 countries.
Detailed Summary
The primary purpose of this study is to evaluate the overall efficacy of aripiprazole intramuscular (IM) depot as acute treatment in subjects with schizophrenia. The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for 12 weeks to adult subjects with schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesCroatia, Latvia, United States
CollaboratorsH. Lundbeck A/S, Otsuka America Pharmaceutical
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartOct 2012
Primary CompletionAug 2013
Study CompletionSep 2013
TodayJul 2026
First PostedAug 13, 2012
Enrollment StartOct 1, 2012
Primary CompletionAug 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.9 years ago
Interventions
Aripiprazole IM Depotdrug
Placebodrug
Matching Placebo