Overview

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

Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators:
H. Lundbeck A/S
Otsuka America Pharmaceutical
Treatments:
Aripiprazole