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 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
604
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
Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)
Time frame: Change from baseline to Week 12
Safety (incidence of adverse events)
Time frame: Week 12
Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)
Time frame: Change from baseline to Week 12
Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale
Time frame: Change from baseline to Week 12
Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale
Time frame: Change from baseline to Week 12
Safety (incidence of adverse events)
Time frame: 60 weeks
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Costa Mesa, California, United States
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Escondido, California, United States
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Granada Hills, California, United States
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La Jolla, California, United States
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Oceanside, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Lauderhill, Florida, United States
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Orange City, Florida, United States
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Plantation, Florida, United States
...and 80 more locations