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Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia

NCT01393613 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 674

Last updated 2015-11-26

Study results available
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Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.

Conditions

  • Acute Schizophrenia

Interventions

DRUG

OPC-34712

Higher dose tablet, once daily, for six weeks,

DRUG

OPC-34712

Middle dose tablet, once daily, for six weeks

DRUG

OPC-34712

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
2014-02-28
Completion
2014-02-28

Countries

  • United States
  • Colombia
  • Croatia
  • Mexico
  • Philippines
  • Russia
  • Slovakia
  • Taiwan

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 NCT01393613 on ClinicalTrials.gov