A clinical trial to study effect of Cariprazine in Patients With Schizophrenia

Phase 3

• Conditions: Health Condition 1: null- Schizophrenia

• Registration Number: CTRI/2012/03/002509
• 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: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 900

Inclusion Criteria

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

•Current diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria as determined by the Structured Clinical Interview for DSM-IV (SCID)

•Patients with normal physical examination, laboratory, vital signs, and/ or ECG

•Diagnosis of schizophrenia for a minimum of 1 year before Visit 1

•PANSS total score greater than or equal to 70 and less than or equal to 120 at Visit 1 and Visit 2

•Negative serum B-human chorionic Gonadotropin (B-hCG) pregnancy test (applies to female patients of childbearing potential only)

•Body mass index between 18 and 40kg/m2, inclusive

Exclusion Criteria

•Patients currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorders

•Patients in their first episode of Psychosis

•Treatment-resistant schizophrenia over the last 2 years

•Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication

•At imminent risk of injuring self or others or causing significant damage to property

•Suicide risk

Study & Design

• Study Type: Interventional
• Study Design: Not specified