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Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00862992
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : September 10, 2009
Information provided by:
Mitsubishi Tanabe Pharma Corporation

Brief Summary:
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets will be administered to patients starting at an initial dose, followed by up-titration to a fixed dose (low, medium or high) for 14 days.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Cariprazine low dose Drug: Cariprazine medium dose Drug: Cariprazine high dose Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of MP-214 in Patients With Schizophrenia (Exploratory Study)
Study Start Date : April 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 1 Drug: Cariprazine low dose
Other Names:
  • Cariprazine(INN)
  • RGH-188

Experimental: 2 Drug: Cariprazine medium dose
Experimental: 3 Drug: Cariprazine high dose

Primary Outcome Measures :
  1. Safety: Adverse event, Adverse drug Reaction

Secondary Outcome Measures :
  1. Pharmacokinetics: Plasma concentration
  2. Efficacy: PANSS total score, CGI-S and CGI-I

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients meeting DSM-IV-TR criteria for schizophrenia
  • PANSS total score <= 120 during the observation period
  • Patients who have been treated with oral antipsychotics within 4 weeks before informed consent
  • Patients whose consent is obtained from themselves in written form

Exclusion Criteria:

  • Patients who have defined as any mental disorder other than "Schizophrenia" based on the criteria of DSM-IV-TR
  • History of drug or alcohol abuse
  • Concurrent Parkinson's disease
  • History of, or concurrent spastic disorders like epilepsy, cerebrovascular disease, anuresis or adynamic(= paralytic) ileus, malignant syndrome, diabetes, hepatic disorder
  • Patients who exhibit abnormalities on Physical Examination, have abnormal vital signs, ECG, or clinical laboratory values
  • Current cataract during the observation period
  • History of shock or anaphylactoid symptoms to drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00862992

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Hoyu Hospital
Kure-City, Hiroshima-ken, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
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Study Chair: Teruhiko Higuchi, President National Center of Neurology and Psychiatry
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Responsible Party: General Manager, Clinical Research Department I, Mitsubishi Tanabe Pharma Corporation Identifier: NCT00862992    
Other Study ID Numbers: A002-A3
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: September 10, 2009
Last Verified: September 2009
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
dopamine D3/D2 antagonist
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs