Status:
COMPLETED
A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)
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 in participants with persistent, predominant negative symptoms ...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
- Predominant negative symptoms
- With the exception of clozapine, participants are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)
Exclusion
- Evidence that participant has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
- Body Mass Index (BMI) of less than (\<) 17 or greater than (\>) 40 kilograms per meter square (kg/m\^2)
- 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 Exrapyramidal Symptoms Rating Scale-Abbreviated (ESRS-A) (Clinical Global Impression, Parkinsonism)
Key Trial Info
Start Date :
December 11 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2014
Estimated Enrollment :
629 Patients enrolled
Trial Details
Trial ID
NCT01192867
Start Date
December 11 2010
End Date
May 26 2014
Last Update
June 26 2017
Active Locations (122)
Enter a location and click search to find clinical trials sorted by distance.
1
K&S Professional Research Services LLC
Little Rock, Arkansas, United States, 72201
2
Advanced Research Center Inc.
Anaheim, California, United States, 92805
3
Comprehensive Clinical Development- Cerritos CA
Cerritos, California, United States, 90703
4
Diligent Clinical Trials Inc
Downey, California, United States, 90241