Clinical Trials Directory

Trials / Completed

CompletedNCT02013622

Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia

Protocol 331-13-006: An Exploratory, Multicenter, Open-label, Monotherapy, Flexible-dose Brexpiprazole (OPC 34712) Trial in Adults With Early Episode Schizophrenia

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
49 (actual)
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
Sex
All
Age
18 Years – 35 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole monotherapy in the improvement of early-episode schizophrenia through the assessment of social functioning, efficacy, and tolerability. Early-episode schizophrenia is defined as episodes occurring ≤ 5 years after the onset of the first episode.

Conditions

Interventions

TypeNameDescription
DRUGBrexpiprazoleTreatment (16 weeks) Up to 4 mg/day, once daily dose, tablets, orally

Timeline

Start date
2013-11-01
Primary completion
2014-09-01
Completion
2014-10-01
First posted
2013-12-17
Last updated
2016-03-29
Results posted
2016-03-29

Locations

22 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02013622. Inclusion in this directory is not an endorsement.

Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia (NCT02013622) · Clinical Trials Directory