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Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia

NCT01668797 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2017-01-13

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.

Conditions

  • Acute Schizophrenia

Interventions

DRUG

Brexpiprazole

Brexpiprazole tablets 1 to 4 mg /day

DRUG

Placebo

Placebo comparator for 52 weeks

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • 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
2012-10-31
Primary Completion
2015-01-31
Completion
2015-02-28

Countries

  • United States
  • Colombia
  • Malaysia
  • Puerto Rico
  • Romania
  • Serbia
  • Turkey (Türkiye)
  • Ukraine

Study Locations

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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 NCT01668797 on ClinicalTrials.gov