A Phase III, multi-center, randomized, 24 week, double-blind, parallel-group, placebo-controlled study to evaluate efficacy and safety of RO4917838 in stable patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics followed by a 28 week double-blind treatment period.
- Conditions
- Treatment of negative symptoms for patients with schizophrenia treated with antipsychotics.MedDRA version: 12.1Level: LLTClassification code 10039626Term: Schizophrenia
- Registration Number
- EUCTR2010-020370-42-HU
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 630
• 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• 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 4. 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method