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Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Phase II Study of MP-214 in Patients With Schizophrenia (Exploratory Study)

NCT00862992•Tanabe Pharma Corporation

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.

Eligibility

Age

20 - 65 years

Sex

ALL

Healthy Volunteers

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
•The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (1)

Hoyu Hospital

Kure, Hiroshima, Japan

Key Dates

Start Date

April 1, 2008

Primary Completion Date

September 1, 2009

Completion Date

September 1, 2009

Last Updated

January 5, 2026

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

Cariprazine 3 mg

DRUG

Cariprazine 6 mg

DRUG

Cariprazine 12.5 mg

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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