A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia
Public ClinicalTrials.gov record NCT01192880. 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 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.
Study identification
- NCT ID
- NCT01192880
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 625 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
- Oct 31, 2010
- Primary completion
- Jun 30, 2014
- Completion
- Jun 30, 2014
- Last update posted
- Feb 14, 2017
2010 – 2014
United States locations
- U.S. sites
- 27
- U.S. states
- 14
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Innovtions Inc | Costa Mesa | California | 92626 | — |
| Synergy Clinical Research of Escondido | Escondido | California | 92025 | — |
| San Fernando Mental Health Center | Granada Hills | California | 91344 | — |
| University of California San Diego | La Jolla | California | 92093 | — |
| Excell Research | Oceanside | California | 92056 | — |
| Artemis Institute for Clinical Research, LLC | San Diego | California | 92103 | — |
| Collaborative Neuroscience Network Inc. | Torrance | California | 90502 | — |
| Behavioral Clinical Research Inc. | Lauderhill | Florida | 33319 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| Medical Research Group of Central Florida | Orange City | Florida | 3273 | — |
| Berma Research Group | Plantation | Florida | 33317 | — |
| Atlanta Center For Medical Research | Atlanta | Georgia | 30308 | — |
| Indiana University; LaRue Carter Memorial Hospital-Research Unit | Indianapolis | Indiana | 46222 | — |
| Clinical Insights, Inc. | Glen Burnie | Maryland | 21061 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
| Altea Research Institute | Las Vegas | Nevada | 89102 | — |
| Ocean Rheumatology | Toms River | New Jersey | 08775 | — |
| State University of New York at Buffalo; Department of Psychiatry | Buffalo | New York | 14215 | — |
| New York State Psychiatric Institute; Psychiatry Dept of Columbia University | New York | New York | 10032 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| Duke University | Durham | North Carolina | 27705 | — |
| Keystone Clinical Studies, LLC | Norristown | Pennsylvania | 19403 | — |
| Scranton Medical Institutes Llc. | Scranton | Pennsylvania | 18503 | — |
| Community Clinical Research Inc. | Austin | Texas | 78754 | — |
| University Hills Clinical Research | Irving | Texas | 75062 | — |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | — |
| 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 76 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01192880, 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 Feb 14, 2017 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01192880 live on ClinicalTrials.gov.