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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Cariprazine

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

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