A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01626859
First received: June 19, 2012
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: MP-214 low dose
Drug: MP-214 middle dose
Drug: MP-214 high dose
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia (12 Weeks Treatment Study)

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Plasma Concentration of MP-214 [ Time Frame: 32 time points up to 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: May 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626859

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

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01626859     History of Changes
Other Study ID Numbers: A002-A11
Study First Received: June 19, 2012
Last Updated: June 3, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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 and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014