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

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

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.

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.