A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)

ClinicalTrials.gov ID: NCT01235559

Public ClinicalTrials.gov record NCT01235559. 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.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:29 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

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: NCT01235559
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 604 participants

Conditions and interventions

Conditions

Schizophrenia

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: Feb 28, 2015
Completion: Feb 28, 2015
Last update posted: Nov 1, 2016

2010 – 2015

United States locations

U.S. sites: 22
U.S. states: 11
U.S. cities: 22

Facility	City	State	ZIP	Site status
Not listed	Costa Mesa	California	92626	—
Not listed	Escondido	California	92025	—
Not listed	Granada Hills	California	91344	—
Not listed	La Jolla	California	92093	—
Not listed	Oceanside	California	92056	—
Not listed	San Diego	California	92103	—
Not listed	Torrance	California	90502	—
Not listed	Lauderhill	Florida	33319	—
Not listed	Orange City	Florida	3273	—
Not listed	Plantation	Florida	33317	—
Not listed	Atlanta	Georgia	30308	—
Not listed	Indianapolis	Indiana	46222	—
Not listed	Flowood	Mississippi	39232	—
Not listed	Las Vegas	Nevada	89102	—
Not listed	Buffalo	New York	14215	—
Not listed	New York	New York	10032	—
Not listed	Rochester	New York	14618	—
Not listed	Durham	North Carolina	27705	—
Not listed	Scranton	Pennsylvania	18503	—
Not listed	Austin	Texas	78754	—
Not listed	Irving	Texas	75062	—
Not listed	Salt Lake City	Utah	84106	—

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 68 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01235559, 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 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01235559 live on ClinicalTrials.gov.

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