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Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

NCT01396421 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 636

Last updated 2015-10-29

Study results available
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Summary

The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.

Conditions

  • Acute Schizophrenia

Interventions

DRUG

OPC-34712 [Brexpiprazole] High Dose

Higher dose, tablet, once daily, for six weeks

DRUG

Experimental: OPC-34712 [Brexpiprazole] Middle Dose

Middle dose, tablet, once daily, for six weeks

DRUG

Experimental: OPC-34712 [Brexpiprazole] Low Dose

Lower dose, tablet, once daily, for six weeks

DRUG

Placebo

Placebo, once daily, for six weeks

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Aleksandar Skuban, M.D. · Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States
  • Canada
  • Japan
  • Latvia
  • Poland
  • Romania
  • Serbia
  • South Korea
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01396421 on ClinicalTrials.gov