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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Cariprazine 3 mg; Drug: Cariprazine 6 mg; Drug: Cariprazine 12.5 mg

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Hiroshima
    • Kure, Hiroshima, Japan
      • Hoyu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Cariprazine 3 mg; Other Names: RGH-188; Cariprazine(INN)
Experimental: 2	Drug: Cariprazine 6 mg
Experimental: 3	Drug: Cariprazine 12.5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Event and Adverse Drug Reaction	Up to 7 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 14 (Last Observation Carried Forward; LOCF)	PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.	at baseline, and on Day 14 or a last observation carried forward (LOCF)
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Day 14 (Last Observation Carried Forward; LOCF)	CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill).	at baseline, and on Day 14 or a last observation carried forward (LOCF)
The Clinical Global Impression-Improvement (CGI-I) Score at Day 14 (Last Observation Carried Forward; LOCF)	CGI-I is a 7-point scale to assess the global improvement of the participant's illness relative to baseline. CGI-I scores range from 1 (very much improved) to 7 (very much worse).	on Day 14 or a last observation carried forward (LOCF)

Collaborators and Investigators

• Sponsor: Tanabe Pharma Corporation
• Investigators: Study Chair: Teruhiko Higuchi, President, National Center of Neurology and Psychiatry

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: March 15, 2009
• First Submitted That Met QC Criteria: March 15, 2009
• First Posted (Estimated): March 17, 2009

Study Record Updates

• Last Update Posted (Estimated): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: schizophrenia; antipsychotics; dopamine D3/D2 antagonist
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; cariprazine
• Other Study ID Numbers: A002-A3