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

NCT ID: NCT00862992

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-09-30

Brief 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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Cariprazine 3 mg

Intervention Type: DRUG

2

Group Type: EXPERIMENTAL

Cariprazine 6 mg

Intervention Type: DRUG

3

Group Type: EXPERIMENTAL

Cariprazine 12.5 mg

Intervention Type: DRUG

Interventions

Cariprazine 3 mg

Intervention Type: DRUG

Cariprazine 6 mg

Intervention Type: DRUG

Cariprazine 12.5 mg

Intervention Type: DRUG

Other Intervention Names

Cariprazine(INN); RGH-188

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teruhiko Higuchi, President

Role: STUDY_CHAIR

National Center of Neurology and Psychiatry

Locations

Hoyu Hospital

Kure, Hiroshima, Japan

Countries

Japan

Other Identifiers

A002-A3

Identifier Type: -

Identifier Source: org_study_id