Placebo
DrugParticipants will receive bitopertin matching placebo once daily for 56 weeks.
NCT Number: NCT01192880
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
DDPDS Prof Dr Ivan Temkov EOOD, Burgas, Bulgaria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive bitopertin matching placebo once daily for 56 weeks.
Participants will receive 10 mg or 20 mg of bitopertin.
Other names: RO4917838
Participants will continue to receive their stable antipsychotic regiment throughout the study. Study protocol does not specify any particular antipsychotic drug and regimen.
Time frame: Baseline, Week 24
Time frame: From baseline up to 24 weeks
Time frame: Baseline, Week 24
Time frame: Baseline, Week 24
Time frame: Baseline, Week 24
Time frame: Baseline, Week 24
Time frame: Week 24
Time frame: Week 24
Time frame: Week 24
Time frame: Baseline, Week 24
Hoffmann-La Roche
Industry
A Phase III, Multi-Center, Randomized, 24 Week, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-Blind Treatment Period
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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