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A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia

This study is currently recruiting participants.
Verified February 2013 by Mitsubishi Tanabe Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01625897
First received: June 19, 2012
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with chronic phase or elderly schizophrenia.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia

Resource links provided by NLM:

U.S. FDA Resources

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: 60 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: May 2012
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 four weeks, then flexible dose of MP-214
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 four weeks, then flexible dose of MP-214
Active Comparator: Risperidone Drug: Risperidone
Patients who meet eligibility criteria will be administered a once daily oral dose of risperidone for two weeks, then flexible dose of risperidone

  Eligibility

Ages Eligible for Study:   20 Years to 74 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 who meet at least one of the following:

    • current diagnosis of schizophrenia of chronic phase
    • between 65 and 74 years of age
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625897

Contacts
Contact: Clinical Trials Information Desk cti-inq-ml@ml.mt-pharma.co.jp

Locations
Japan
Recruiting
Aizuwakamatsu, Fukushima, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01625897     History of Changes
Other Study ID Numbers: A002-A7
Study First Received: June 19, 2012
Last Updated: February 6, 2013
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
Risperidone
Central Nervous System Agents

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Central Nervous System Agents
Risperidone
Antipsychotic Agents
Therapeutic Uses
Pharmacologic Actions
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 16, 2013