A Phase 3 interventional study of Placebo and bitopertin [RO4917838] in Schizophrenia, sponsored by Hoffmann-La Roche. Completed at 120 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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.
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's enrollment of 597 is above the median of 70 across 2,924 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.
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Drug: bitopertin [RO4917838]
Drug: bitopertin [RO4917838]
Drug: Placebo
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
Showing the first 100 of 120 sites across 14 countries.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bitopertin