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Completed

NCT Number: NCT01626859

A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia

The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of MP-214 in patients with schizophrenia.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sakai, Osaka, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent obtained from the patient before the initiation of any study-specific procedures
  • Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
  • Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion criteria

  • Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

MP-214 3mg

Drug

Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.

MP-214 6mg

Drug

Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.

MP-214 9mg

Drug

Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.

Primary outcomes

  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Time frame: Up to 24 weeks

  2. Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84

    Time frame: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.

  3. Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84

    Time frame: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.

  4. Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84

    Time frame: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia (12 Weeks Treatment Study)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 25, 2012
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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