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A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01626859
Recruitment Status : Completed
First Posted : June 25, 2012
Last Update Posted : June 5, 2014
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: MP-214 low dose Drug: MP-214 middle dose Drug: MP-214 high dose Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia (12 Weeks Treatment Study)
Study Start Date : May 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: MP-214 low dose Drug: MP-214 low dose
Patients who meet eligibility criteria will be administered a once daily oral low dose of MP-214 for twelve weeks.

Experimental: MP-214 middle dose Drug: MP-214 middle dose
Patients who meet eligibility criteria will be administered a once daily oral middle dose of MP-214 for twelve weeks.

Experimental: MP-214 high dose Drug: MP-214 high dose
Patients who meet eligibility criteria will be administered a once daily oral high dose of MP-214 for twelve weeks.




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 weeks ]
  2. Pharmacokinetics: Plasma Concentration of MP-214 [ Time Frame: 32 time points up to 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626859


Locations
Japan
Sakai, Osaka, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01626859     History of Changes
Other Study ID Numbers: A002-A11
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: June 5, 2014
Last Verified: June 2014

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Schizophrenia
Antipsychotic Agents
Mental Disorder
Psychotropic Drugs
Dopamine Agents
Central Nervous System Agents

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders