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Trial record 16 of 551 for:    Open Studies | "Schizophrenia"
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Safety and Efficacy of MP-214 in Patients With Schizophrenia

This study is currently recruiting participants.
Verified December 2012 by Mitsubishi Tanabe Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01625000
First received: June 19, 2012
Last updated: December 27, 2012
Last verified: December 2012
History of Changes
  Purpose

The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of MP-214 in Patients With Schizophrenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Change in the Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the Clinical Global Impression-Severity (CGI-S) score [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
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 six 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 six 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 six weeks.
Active Comparator: Risperidone Drug: Risperidone
Patients who meet eligibility criteria will be administered a once daily oral dose of risperidone for six weeks.
Placebo Comparator: Placebo Drug: Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625000

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

Locations
Japan
Recruiting
Sapporo, Hokkaido, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01625000     History of Changes
Other Study ID Numbers: A002-A4
Study First Received: June 19, 2012
Last Updated: December 27, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
Korea: Food and Drug Administration
Taiwan : Food and Drug Administration

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Schizophrenia
Antipsychotic Agents
Acute Schizophrenia
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