A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia
Completed
Hoffmann-La Roche
Phase 3
This Phase 3, multi-center, randomized, double blind, parallel-group, placebo-controlled
study will evaluate the efficacy and safety of RO4917838 (bitopertin) in participants with
persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment
with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching
placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.
A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)
Completed
Hoffmann-La Roche
Phase 3
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 symptoms of schizophrenia. Patients, on stable treatment with
antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching
placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.
A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia
Completed
Hoffmann-La Roche
Phase 2
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. Patients will be randomized to receive either RO4917838 10 mg
or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients,
with a 4-week follow-up period.
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