Safety and Efficacy of MP-214 in Patients With Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 8, 2014
Last verified: July 2014
  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:


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
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: NCT01625000

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

Locations
Japan
Recruiting
Sapporo, Hokkaido, Japan
Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Taiwan
Recruiting
Taipei, Taiwan
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: July 8, 2014
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
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014