Safety and Efficacy of MP-214 in Patients With Schizophrenia

Last updated: April 8, 2021
Sponsor: Mitsubishi Tanabe Pharma Corporation
Overall Status: Completed

Phase

2/3

Condition

Mood Disorders

Schizotypal Personality Disorder (Spd)

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT01625000
A002-A4
  • Ages 20-64
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent obtained from the patient before the initiation of anystudy-specific procedures
  • Patients diagnosed with schizophrenia according to the diagnostic criteria of theDiagnostic 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/orelectrocardiogram (ECG)

Exclusion

Exclusion Criteria:

  • Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniformdisorder, other psychotic disorders other than schizophrenia, or bipolar I or IIdisorder The information is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial.

Study Design

Total Participants: 512
Study Start date:
May 01, 2012
Estimated Completion Date:
October 31, 2015

Connect with a study center

  • Sapporo, Hokkaido
    Japan

    Site Not Available

  • Seoul,
    Korea, Republic of

    Site Not Available

  • Taipei,
    Taiwan

    Site Not Available

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