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Safety and Efficacy of MP-214 in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MP-214 3mg
MP-214 6mg
MP-214 9mg
Risperidone 4mg
Placebo
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Antipsychotic Agents, Acute Schizophrenia, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Risperidone, Central Nervous System Agents

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

MP-214 3mg

MP-214 6mg

MP-214 9mg

Risperidone 4mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.

Secondary Outcome Measures

Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6
CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill).

Full Information

First Posted
June 19, 2012
Last Updated
April 8, 2021
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01625000
Brief Title
Safety and Efficacy of MP-214 in Patients With Schizophrenia
Official Title
A Double-Blind, Placebo-Controlled Study of MP-214 in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Antipsychotic Agents, Acute Schizophrenia, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Risperidone, Central Nervous System Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
512 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MP-214 3mg
Arm Type
Experimental
Arm Title
MP-214 6mg
Arm Type
Experimental
Arm Title
MP-214 9mg
Arm Type
Experimental
Arm Title
Risperidone 4mg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MP-214 3mg
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
Intervention Type
Drug
Intervention Name(s)
MP-214 6mg
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
Intervention Type
Drug
Intervention Name(s)
MP-214 9mg
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
Intervention Type
Drug
Intervention Name(s)
Risperidone 4mg
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
Primary Outcome Measure Information:
Title
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
Description
PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.
Time Frame
Baseline and Week 6
Secondary Outcome Measure Information:
Title
Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6
Description
CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill).
Time Frame
Baseline and Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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 The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Facility Information:
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Seoul
Country
Korea, Republic of
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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Safety and Efficacy of MP-214 in Patients With Schizophrenia

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