Safety and Efficacy of Cariprazine in Schizophrenia.

Phase 3

Completed

• Conditions: Health Condition 1: null- Acute SchizophreniaHealth Condition 2: F209- Schizophrenia, unspecified

• Registration Number: CTRI/2010/091/001068
• Lead Sponsor: Forest Research Institute Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 450

Inclusion Criteria

Male or female patients who are 18 to 60 years of age

Patients who have provided informed consent prior to any study specific procedures

Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of schizophrenia symtopms: Positive and Negative Syndrome Scale (PANSS) total score,Timepoint: 6 Weeks

Secondary Outcome Measures

Name	Time	Method
Measurement of schizophrenia symtopms: Clinical Global Impression-Severity (CGI-S)Timepoint: 6 Weeks