Safety and Efficacy of MP-214 in Patients With Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: MP-214 9mg; Drug: Risperidone 4mg; Drug: Placebo; Drug: MP-214 3mg; Drug: MP-214 6mg

• Registration Number: NCT01625000
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-21
• Primary Completion: 2015-08
• Study Completion: 2015-10
• Results First Submitted: 2021-01-11
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Results First Posted: 2021-04-12
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 512

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MP-214 9mg	MP-214 9mg	-
Risperidone 4mg	Risperidone 4mg	-
Placebo	Placebo	-
MP-214 3mg	MP-214 3mg	-
MP-214 6mg	MP-214 6mg	-

Primary Outcome Measures

Name	Time	Method
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6	Baseline and 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

Name	Time	Method
Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6	Baseline and 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).