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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
624
Oral doses, once a day for 52 weeks
Oral dose level 1, once a day for 52 weeks
Oral dose level 2, once a day for 52 weeks
Efficacy (PANSS negative symptoms factor score)
Time frame: Week 24
Safety (incidence of adverse events)
Time frame: Week 24
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Carson, California, United States
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Oceanside, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Hartford, Connecticut, United States
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Norwalk, Connecticut, United States
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North Miami, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Hoffman Estates, Illinois, United States
...and 103 more locations