Status:
COMPLETED
A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This randomized, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia...
Eligibility Criteria
Inclusion
- Adult patients, 18-65 years of age
- Diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders DSM IV-TR)
- Acute exacerbation which began within the prior 8 weeks
- Female patients must be surgically sterile or post-menopausal, or agree to use effective contraception for the duration of the study
Exclusion
- Current psychiatric diagnosis other than schizophrenia
- Alcohol or substance dependence within 3 months or abuse within 1 month (except for nicotine)
- Electro-convulsive therapy (ECT) within the prior 6 months
- Previous treatment with RO4917838 or another GLYT inhibitor
- Current treatment with olanzapine, or previous treatment with intolerability or lack of response
- Treatment with long-acting injectable antipsychotic within 2 dosing intervals
- Treatment with \> 2 antipsychotics within 3 months
- History of neuroleptic malignant syndrome
- Have treatment-resistant schizophrenia as judged by treating physician or have failed two trials according to criteria in protocol
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT01234779
Start Date
February 1 2011
End Date
September 1 2012
Last Update
November 2 2016
Active Locations (46)
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1
Little Rock, Arkansas, United States, 72201
2
Cerritos, California, United States, 90703
3
Oceanside, California, United States, 92056
4
Pico Rivera, California, United States, 90660