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

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Cariprazine 6 mg; Drug: Cariprazine 3 mg; Drug: Cariprazine 12.5 mg

• Registration Number: NCT00862992
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-03-15
• Study First Submitted QC: 2009-03-15
• Study First Posted: 2009-03-17
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2021-01-11
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Results First Posted: 2021-04-12
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Cariprazine 6 mg	-
1	Cariprazine 3 mg	-
3	Cariprazine 12.5 mg	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Event and Adverse Drug Reaction	Up to 7 weeks

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14	Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.
Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14	Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14	Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.

Trial Locations

Locations (1)

Hoyu Hospital; 🇯🇵 Kure-City, Hiroshima-ken, Japan