Status:
COMPLETED
A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)
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 (bitopertin) in patients with sub-optimally controlled symptoms ...
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 :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
604 Patients enrolled
Trial Details
Trial ID
NCT01235559
Start Date
December 1 2010
End Date
March 1 2015
Last Update
November 2 2016
Active Locations (90)
Enter a location and click search to find clinical trials sorted by distance.
1
Costa Mesa, California, United States, 92626
2
Escondido, California, United States, 92025
3
Granada Hills, California, United States, 91344
4
La Jolla, California, United States, 92093