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NCT01235585 · ClinicalTrials.gov registry record · Phase 3
A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 597
- Enrollment target
NCT01235585: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01235585 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 597 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01235585, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 597 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG bitopertin [RO4917838]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 597 participants |
| Start Date | 2010-12 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT01235585 record still lists
NCT01235585 is an interventional study that assigns participants to a tested intervention. The registered 597 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 (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01235585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01235585 about?
NCT01235585 is a clinical study titled "A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)". 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 ...
What is the current status of trial NCT01235585?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 597 participants. The study started on 2010-12. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01235585?
The interventions under investigation include: Placebo (DRUG), bitopertin [RO4917838] (DRUG).
Who is sponsoring clinical trial NCT01235585?
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 NCT01235585's enrollment target sits among peer trials
597 640th of 2000 higher than 1,361 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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