NCT01663532

Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Aripiprazole IM Depot
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2012-08-13
• Last updated: 2015-02-16
• Results posted: 2015-02-16

Locations

49 sites across 3 countries: United States, Croatia, Latvia