Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 3 Interventional

A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia

ClinicalTrials.gov ID: NCT01192880

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.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 7:34 PM EDT

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
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
625 participants

Conditions and interventions

Conditions

Interventions

Drug

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
Nov 2010 (Type not available)
Primary completion
Jul 2014 (Actual)
Completion
Jul 2014 (Actual)
Last update posted
Feb 15, 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 15, 2017 · Synced Oct 24, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01192880 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →