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

Tanabe Pharma Corporation

Status and phase

Completed

Phase 2

Conditions

Schizophrenia

Treatments

Drug: Cariprazine 6 mg

Drug: Cariprazine 3 mg

Drug: Cariprazine 12.5 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00862992

A002-A3

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No 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.