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Completed Phase 3 Interventional

A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)

ClinicalTrials.gov ID: NCT01235585

Public ClinicalTrials.gov record NCT01235585. 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 Sep 3, 2026, 8:51 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase III, Multi-center, Randomized, 12-week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 40-week Double-blind, Parallel-group, Placebo-controlled Treatment Period.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled symptoms of schizophrenia. Patients, 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
NCT01235585
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
597 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 30, 2010
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014
Last update posted
Nov 1, 2016

2010 – 2014

United States locations

U.S. sites
25
U.S. states
11
U.S. cities
22
Facility City State ZIP Site status
Not listed Carson California 90746
Not listed Garden Grove California 92845
Not listed Long Beach California 90813
Not listed Long Beach California 90822
Not listed Oceanside California 92056
Not listed San Diego California 92121
Not listed San Diego California 92123
Not listed Hartford Connecticut 06106
Not listed Norwalk Connecticut 06851
Not listed North Miami Florida 33161
Not listed Atlanta Georgia 30328
Not listed Chicago Illinois 60612
Not listed Hoffman Estates Illinois 60169
Not listed Joliet Illinois 60435
Not listed Lake Charles Louisiana 70601
Not listed St Louis Missouri 63128
Not listed St Louis Missouri 63141
Not listed Omahac Nebraska 68131
Not listed Cedarhurst New York 11516
Not listed Jamaica New York 11418
Not listed Rochester New York 14623
Not listed Allentown Pennsylvania 18104
Not listed Norristown Pennsylvania 19403
Not listed Philadelphia Pennsylvania 19139
Not listed Bothell Washington 98011

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 NCT01235585, 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 Nov 1, 2016 · Synced Sep 3, 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 protocol, eligibility criteria, and contact information for NCT01235585 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →