A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia

NCT ID: NCT01626859

Last Updated: 2026-01-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-08-31

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MP-214 3mg

Group Type EXPERIMENTAL

MP-214 3mg

Intervention Type DRUG

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

MP-214 6mg

Group Type EXPERIMENTAL

MP-214 6mg

Intervention Type DRUG

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

MP-214 9mg

Group Type EXPERIMENTAL

MP-214 9mg

Intervention Type DRUG

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

Interventions

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MP-214 3mg

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

Intervention Type DRUG

MP-214 6mg

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

Intervention Type DRUG

MP-214 9mg

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sakai, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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A002-A11

Identifier Type: -

Identifier Source: org_study_id

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