This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time o n study treatment is \<3 months, and the target sample size is 100-500 individual s.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
323
Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score.
Time frame: Week 8
Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes.
Time frame: Throughout study
AEs, laboratory parameters, C-SSRS
Time frame: Throughout study
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po daily
As prescribed
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Granada Hills, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Torrance, California, United States
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Atlanta, Georgia, United States
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Hoffman Estates, Illinois, United States
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Brooklyn, New York, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
...and 63 more locations