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
- Schizophrenia10039628
- Registration Number
- NL-OMON37510
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 18
• 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);For all inclusion criteria, please see protocol.
• Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
• Patient with body mass index (BMI) < 17 kg/m2 or > 40
kg/m2
• Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)
• A severity score of 3 or greater on the Parkinsonism item of
the ESRS-A (Clinical Global Impression, Parkinsonism).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Efficacy (PANSS negative symptoms factor score)<br /><br>2. Safety (incidence of adverse events)</p><br>
- Secondary Outcome Measures
Name Time Method