Safety and Efficacy of MP-214 in Patients With Schizophrenia

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: MP-214 3mg
* Drug: MP-214 6mg
* Drug: MP-214 9mg
* Drug: Risperidone 4mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MP-214 3mg<br> | Drug: MP-214 3mg<br>* Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.<br>|
| Experimental: MP-214 6mg<br> | Drug: MP-214 6mg<br>* Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.<br>|
| Experimental: MP-214 9mg<br> | Drug: MP-214 9mg<br>* Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.<br>|
| Active Comparator: Risperidone 4mg<br> | Drug: Risperidone 4mg<br>* Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Antipsychotic Agents, Acute Schizophrenia, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Risperidone, Central Nervous System Agents