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Safety and Efficacy of MP-214 in Patients With Schizophrenia

NCT01625000 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2026-01-05

Study results available
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Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.

Conditions

Interventions

DRUG

MP-214 3mg

Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.

DRUG

MP-214 6mg

Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.

DRUG

MP-214 9mg

Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.

DRUG

Risperidone 4mg

Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.

DRUG

Placebo

Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-08-31
Completion
2015-10-31

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

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Entities

Drugs
Diseases

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 NCT01625000 on ClinicalTrials.gov