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.
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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
Drug: Cariprazine low doseDrug: Cariprazine medium doseDrug: Cariprazine high dose
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Ages Eligible for Study:
20 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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