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

This study has been completed.
Sponsor:
Information provided by:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00862992
First received: March 15, 2009
Last updated: September 8, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Cariprazine low dose
Drug: Cariprazine medium dose
Drug: Cariprazine high dose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of MP-214 in Patients With Schizophrenia (Exploratory Study)

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Safety: Adverse event, Adverse drug Reaction

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

Estimated Enrollment: 30
Study Start Date: April 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Cariprazine low dose
Other Names:
  • Cariprazine(INN)
  • RGH-188
Experimental: 2 Drug: Cariprazine medium dose
Experimental: 3 Drug: Cariprazine high dose

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862992

Locations
Japan
Hoyu Hospital
Kure-City, Hiroshima-ken, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Chair: Teruhiko Higuchi, President National Center of Neurology and Psychiatry
  More Information

No publications provided

Responsible Party: General Manager, Clinical Research Department I, Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00862992     History of Changes
Other Study ID Numbers: A002-A3
Study First Received: March 15, 2009
Last Updated: September 8, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
schizophrenia
antipsychotics
dopamine D3/D2 antagonist

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

ClinicalTrials.gov processed this record on November 24, 2014