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Completed

NCT Number: NCT01625000

Safety and Efficacy of MP-214 in Patients With Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sapporo, Hokkaido, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MP-214 3mg

Drug

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

MP-214 6mg

Drug

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

MP-214 9mg

Drug

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

Risperidone 4mg

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6

    Time frame: Baseline and Week 6

    PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.

Secondary outcomes

  1. Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6

    Time frame: Baseline and Week 6

    CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill).

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled Study of MP-214 in Patients With Schizophrenia

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 21, 2012
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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