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NCT01192867 · ClinicalTrials.gov registry record · Phase 3
A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)
A Phase 3 study of Schizophrenia, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 629
- Enrollment target
- 20
- Study locations
NCT01192867 is a Phase 3 study of Schizophrenia that has completed, run by Hoffmann-La Roche. The registered enrollment target is 629 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (190% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT01192867, a Phase 3 study of Schizophrenia, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 629 participants
- Enrollment target
- 20
- Study locations
Study Summary
This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 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 56 weeks (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional treatment extension for up to 3 years. After 52 weeks, participants who were originally randomized to an active treatment will be randomly assigned to receive either placebo or continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to Week 56) for the assessment of potential withdrawal effects in a blinded manner using participants staying on active treatment as a control. Participants initially randomized to placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in the washout period will return to their blinded, active treatment arm.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RO4917838
- DRUG Antipshychotics (Standard of Care)
Study Locations (20)
California
- Advanced Research Center Inc. - Anaheim
- Comprehensive Clinical Development- Cerritos CA - Cerritos
- Diligent Clinical Trials Inc - Downey
- Care Research Center - La Palma
- Pasadena Research Institute - Pasadena
- CNRI - Los Angeles, LLC - Pico Rivera
New Jersey
- Ocean Rheumatology - Toms River
- CRI Worldwide LLC - Willingboro
New York
- Behavioral Medical Research of Brooklyn - Brooklyn
- Comprehensive NeuroScience - Fresh Meadows
Arkansas
- K&S Professional Research Services LLC - Little Rock
Florida
- Pharmax Research Clinic Inc. - Miami
Georgia
- Northwest Behavioral Research Center - Marietta
Illinois
- American Medical Research, Inc - Oak Brook
Iowa
- University of Iowa College of Medicine; Psychiatry Research - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 629 participants |
| Start Date | 2010-12-11 |
| Est. Completion | 2014-05-26 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01192867
The ClinicalTrials.gov registry entry for NCT01192867 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 629 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (190% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01192867 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT01192867 about?
NCT01192867 is a clinical study titled "A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)". This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics, will be randomized to recei...
What is the current status of trial NCT01192867?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 629 participants. The study started on 2010-12-11. Estimated completion is 2014-05-26.
What conditions does trial NCT01192867 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT01192867?
The interventions under investigation include: Placebo (DRUG), RO4917838 (DRUG), Antipshychotics (Standard of Care) (DRUG).
Who is sponsoring clinical trial NCT01192867?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01192867 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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