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NCT Number: NCT00862992

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hoyu Hospital

Kure, Hiroshima, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cariprazine 3 mg

Drug

Other names: Cariprazine(INN), RGH-188

Cariprazine 6 mg

Drug

Cariprazine 12.5 mg

Drug

Primary outcomes

  1. Number of Participants With Adverse Event and Adverse Drug Reaction

    Time frame: Up to 7 weeks

Secondary outcomes

  1. Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14

    Time frame: Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.

  2. Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14

    Time frame: Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.

  3. 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

    Time frame: Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.

Other outcomes

  1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 14 (Last Observation Carried Forward; LOCF)

    Time frame: at baseline, and on Day 14 or a 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.

  2. Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Day 14 (Last Observation Carried Forward; LOCF)

    Time frame: at baseline, and on Day 14 or a 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).

  3. The Clinical Global Impression-Improvement (CGI-I) Score at Day 14 (Last Observation Carried Forward; LOCF)

    Time frame: on Day 14 or a 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).

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

Phase II Study of MP-214 in Patients With Schizophrenia (Exploratory Study)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 17, 2009
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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