Safety and Efficacy of MP-214 in Patients With Schizophrenia

NCT ID: NCT01625000

Last Updated: 2026-01-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MP-214 3mg

Group Type EXPERIMENTAL

MP-214 3mg

Intervention Type DRUG

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

MP-214 6mg

Group Type EXPERIMENTAL

MP-214 6mg

Intervention Type DRUG

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

MP-214 9mg

Group Type EXPERIMENTAL

MP-214 9mg

Intervention Type DRUG

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

Risperidone 4mg

Group Type ACTIVE_COMPARATOR

Risperidone 4mg

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MP-214 3mg

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

Intervention Type DRUG

MP-214 6mg

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

Intervention Type DRUG

MP-214 9mg

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

Intervention Type DRUG

Risperidone 4mg

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Written informed consent obtained from the patient before the initiation of any study-specific procedures
* Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
* Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria

* Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sapporo, Hokkaido, Japan

Site Status

Seoul, , South Korea

Site Status

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan South Korea Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A002-A4

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Schizophrenia Study In Adults
NCT00049946 COMPLETED PHASE2