A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of MP-214 in patients with schizophrenia.

Official Title
-----------------
A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia (12 Weeks Treatment Study)

Conditions
-----------------
Schizophrenia

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


Participation Criteria
=================
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.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


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 twelve 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 twelve 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 twelve weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability |  | Up to 24 weeks | 
| Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 |  | On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose. | 
| Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 |  | On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose. | 
| Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 |  | On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose. | 

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