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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
625
Participants will receive bitopertin matching placebo once daily for 56 weeks.
Participants will receive 10 mg or 20 mg of bitopertin.
Participants will continue to receive their stable antipsychotic regiment throughout the study. Study protocol does not specify any particular antipsychotic drug and regimen.
Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Symptom Factor Score at Week 24
Time frame: Baseline, Week 24
Percentage of Participants with Adverse Events
Time frame: From baseline up to 24 weeks
Mean Change from Baseline in the Personal and Social Performance (PSP) Total Score at Week 24
Time frame: Baseline, Week 24
Mean Change from Baseline in the PANSS Total Score at Week 24
Time frame: Baseline, Week 24
Mean Change from Baseline in the PANSS Factor Scores at Week 24
Time frame: Baseline, Week 24
Mean Change from Baseline in the PANSS Subscale Scores at Week 24
Time frame: Baseline, Week 24
Percentage of Participants With Response, as Assessed by PANSS Negative Symptom Factor Score
Time frame: Week 24
Percentage of Participants with Response, as Assessed by CGI-I Overall and Negative Symptoms Rating Score
Time frame: Week 24
Percentage of Participants with Both At Least 20% Improvement from Baseline in the PANSS Negative Symptom Factor Score and with a CGI-I Negative Symptoms Rating of Either Much or Very Much Improvement
Time frame: Week 24
Mean Change from Baseline in the CGI-S Overall and Negative Symptoms Rating Score
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Time frame: Baseline, Week 24