Health Condition 1: null- Schizophrenia
Conditions
Interventions
Intervention1: Cariprazine: Patients who meet eligibility criteria will be administered a once daily oral dose of 3.0 to 9.0 mg cariprazine during the open-label phase and then randomized when they wi
Sponsors
Forest Research Institute Inc
Quintiles Research India Pvt Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from baseline to the first symptom relapse during the Double-Blind phaseTimepoint: At 20 Weeks and Bi-Weekly thereafter until week 92 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from baseline to the first symptom relapse during the Double-Blind phaseTimepoint: At 20 Weeks and Bi-Weekly thereafter until week 92 | — |
Countries
Argentina, Bulgaria, India, Romania, Slovakia, Ukraine, United States of America
Contacts
Public ContactSuchela Srivatsa
Quintiles Research (India) Pvt. Ltd.
Outcome results
None listed