Safety and Efficacy of MP-214 in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled Study of MP-214 in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625000
• Other study ID #: A002-A4
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2012
• Est. completion date: October 2015

Study information

• Verified date: April 2021
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• MP-214 3mg
Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
• MP-214 6mg
Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
• MP-214 9mg
Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
• Risperidone 4mg
Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
• Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Week 6
Secondary	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).	Baseline and Week 6