Status:
COMPLETED
A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with persistent, predominant negative ...
Eligibility Criteria
Inclusion
- 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
- Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
- Body Mass Index (BMI) of \<17 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)
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT01192906
Start Date
December 1 2010
End Date
July 1 2014
Last Update
November 2 2016
Active Locations (113)
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Carson, California, United States, 90746
2
Oceanside, California, United States, 92056
3
San Diego, California, United States, 92121
4
San Diego, California, United States, 92123