CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 74 enrolled
Drug / intervention
Aripiprazole IM Depotdrug
Likely dose
Aripiprazole IM Depot 400 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.

Search/NCT01683058
NCT01683058Phase 3Completed
CompareCT.gov

A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Sep 11, 2012·Updated Mar 31, 2015

In Brief

A Phase 3 clinical trial evaluating Aripiprazole IM Depot for Schizophrenia. Completed, enrolled 74 participants across 38 sites in 3 countries.

Detailed Summary

The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the treatment of adults experiencing an acute relapse of schizophrenia. Subjects receive treatment during a 12-week double-blind acute treatment phase. The current trial (31-12-297) will allow the subjects who complete Trial 291 to enter this open label trial at the investigator's discretion, where additional safety and tolerability data will be collected.

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 PostedSep 11, 2012
Enrollment StartJan 1, 2013
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.8 years ago

Interventions

Aripiprazole IM Depotdrug

Aripiprazole IM Depot 400 mg or 300 mg