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NCT01116830 · ClinicalTrials.gov registry record · Phase 1
A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT01116830: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01116830 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01116830, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
This randomized, double-blind, placebo-controlled parallel group study will assess the effect on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of RO4917838 in participants with schizophrenia and schizoaffective disorder. Participants will be randomized to receive either RO4917838 (10 milligrams \[mg\] daily orally) or placebo for 6 weeks, in addition to their stable antipsychotic medication. Anticipated time on study treatment is 6 weeks.
Interventions
- DRUG Placebo
- DRUG RO4917838
- DRUG Standard Antipsychotic Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2010-11 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
What the finished NCT01116830 record still lists
NCT01116830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01116830 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01116830 about?
NCT01116830 is a clinical study titled "A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder". This randomized, double-blind, placebo-controlled parallel group study will assess the effect on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of RO4917838 in participants with schizophrenia and schizoaffective disorder. Participants will be randomized to receive eit...
What is the current status of trial NCT01116830?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2010-11. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01116830?
The interventions under investigation include: Placebo (DRUG), RO4917838 (DRUG), Standard Antipsychotic Therapy (DRUG).
Who is sponsoring clinical trial NCT01116830?
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 NCT01116830's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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