A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)
Public ClinicalTrials.gov record NCT01192867. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Multi-Center, Randomized, 24 Week, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-Blind Treatment Period
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01192867
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 629 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 11, 2010 (Actual)
- Primary completion
- May 26, 2014 (Actual)
- Completion
- May 26, 2014 (Actual)
- Last update posted
- Jun 26, 2017
2010 – 2014
United States locations
- U.S. sites
- 27
- U.S. states
- 16
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| K&S Professional Research Services LLC | Little Rock | Arkansas | 72201 | — |
| Advanced Research Center Inc. | Anaheim | California | 92805 | — |
| Comprehensive Clinical Development- Cerritos CA | Cerritos | California | 90703 | — |
| Diligent Clinical Trials Inc | Downey | California | 90241 | — |
| Care Research Center | La Palma | California | 90623 | — |
| Pasadena Research Institute | Pasadena | California | 91106 | — |
| CNRI - Los Angeles, LLC | Pico Rivera | California | 90660 | — |
| Pharmax Research Clinic Inc. | Miami | Florida | 33126 | — |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | — |
| American Medical Research, Inc | Oak Brook | Illinois | 60523 | — |
| University of Iowa College of Medicine; Psychiatry Research | Iowa City | Iowa | 52242 | — |
| Clinical Insights, Inc. | Glen Burnie | Maryland | 21061 | — |
| St Louis Clinical Trials | St Louis | Missouri | 63141 | — |
| Ocean Rheumatology | Toms River | New Jersey | 08775 | — |
| CRI Worldwide LLC | Willingboro | New Jersey | 08046 | — |
| Raymond G. Murphy VA Medical Center | Albuquerque | New Mexico | 87108 | — |
| Behavioral Medical Research of Brooklyn | Brooklyn | New York | 11201 | — |
| Comprehensive NeuroScience | Fresh Meadows | New York | 11366 | — |
| North Carolina Psychiatric Research Center | Raleigh | North Carolina | 27603 | — |
| UC Health Clinical Trials Office | Cincinnati | Ohio | 45267 | — |
| Belmont Center for Comprehensive Treatment; Research | Philadelphia | Pennsylvania | 19131 | — |
| Claghorn-Lesem Research Clinic, Inc. | Bellaire | Texas | 77401 | — |
| FutureSearch Clinical Trials, LP | Dallas | Texas | 75231 | — |
| Pillar Clinical Research LLC | Dallas | Texas | 75243 | — |
| Family Psychiatry of the Woodlands P.A. | The Woodlands | Texas | 77381 | — |
| Pacific Institute of Medical Sciences | Bothell | Washington | 98011 | — |
| Eastside Therapeutic Resource | Kirkland | Washington | 98033 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 95 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01192867, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 26, 2017 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01192867 live on ClinicalTrials.gov.