Status:
COMPLETED
A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled symptoms of schizophr...
Eligibility Criteria
Inclusion
- Adult patients, \>/= 18 years of age
- Diagnosis of schizophrenia
- Clinical stability for 16 weeks (4 months) prior to randomization
- Antipsychotic treatment stability for the past 12 weeks prior to randomization
- With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics)
Exclusion
- Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials
- Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease)
- Patient has a body mass index (BMI) of \<17 or \>40 kg/m2, respectively
- Diagnosis of mental retardation or severe organic brain syndromes
- In the investigator's judgment, a significant risk of suicide or violent behavior
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
595 Patients enrolled
Trial Details
Trial ID
NCT01235520
Start Date
January 1 2011
End Date
July 1 2014
Last Update
June 2 2015
Active Locations (121)
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1
Little Rock, Arkansas, United States, 72201
2
Little Rock, Arkansas, United States, 72211
3
Buena Park, California, United States, 90620
4
Cerritos, California, United States, 90703