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Glycine Transporter Inhibitor

Bitopertin oral dose level 1 for Schizophrenia

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Bitopertin oral dose level 2Experimental Treatment1 Intervention
Group II: Bitopertin oral dose level 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bitopertin
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,450 Previous Clinical Trials
1,094,886 Total Patients Enrolled
18 Trials studying Schizophrenia
7,438 Patients Enrolled for Schizophrenia
Clinical TrialsStudy DirectorHoffmann-La Roche
2,220 Previous Clinical Trials
894,793 Total Patients Enrolled
17 Trials studying Schizophrenia
7,857 Patients Enrolled for Schizophrenia
~40 spots leftby Oct 2025
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