A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia

This study has been completed.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
First received: June 19, 2012
Last updated: January 22, 2015
Last verified: January 2015
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with receiving multiple drugs schizophrenia.

Condition Intervention Phase
Drug: MP-214
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia

Resource links provided by NLM:

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 60 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: May 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MP-214 Drug: MP-214
Patients who meet eligibility criteria will be administered a once daily oral low dose of MP-214 for four weeks, then flexible dose of MP-214


Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 who receive 1 or more antipsychotic drugs
  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01626885

Kurayoshi, Tottori, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01626885     History of Changes
Other Study ID Numbers: A002-A8 
Study First Received: June 19, 2012
Last Updated: January 22, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Antipsychotic Agents
Mental Disorder
Psychotropic Drugs
Dopamine Agents
Central Nervous System Agents

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 10, 2016