A Study of RG1678(RO4917838) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia.
Phase 3
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2080221370
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 630
Inclusion Criteria
Adult patients, aged 18 years and above
-Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
-Predominant negative symptoms
-With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)
Exclusion Criteria
-Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
-Body Mass Index (BMI) <18.5 or >40
-Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)
-A score of 3 or greater on the global Parkinsonism item of the ESRS-A
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method