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NCT01192880 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 625
- Enrollment target
NCT01192880: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01192880 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 625 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01192880, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 625 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG Antipsychotics
- DRUG Bitopertin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 625 participants |
| Start Date | 2010-11 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
What the finished NCT01192880 record still lists
NCT01192880 is an interventional study that assigns participants to a tested intervention. The registered 625 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01192880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01192880 about?
NCT01192880 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia". 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 ...
What is the current status of trial NCT01192880?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 625 participants. The study started on 2010-11. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01192880?
The interventions under investigation include: Placebo (DRUG), Antipsychotics (DRUG), Bitopertin (DRUG).
Who is sponsoring clinical trial NCT01192880?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01192880's enrollment target sits among peer trials
625 586th of 2000 higher than 1,414 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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