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A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305) | Clinical Trials | Clareo Health

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

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.

NCT01235559•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Diagnosis of schizophrenia
•Clinical stability for 16 weeks (4 months) prior to randomization
•Antipsychotic treatment stability for the past 12 weeks prior to randomization
•With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics)

Exclusion Criteria

•Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials
•Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease)
•Patient has a body mass index (BMI) of \<17 or \>40 kg/m2, respectively)
•Diagnosis of mental retardation or severe organic brain syndromes
•In the investigator's judgment, a significant risk of suicide or violent behavior"

Locations (90)

Costa Mesa, California, United States

Escondido, California, United States

Granada Hills, California, United States

La Jolla, California, United States

Oceanside, California, United States

San Diego, California, United States

Torrance, California, United States

Lauderhill, Florida, United States

Orange City, Florida, United States

Plantation, Florida, United States

Key Dates

Start Date

December 1, 2010

Primary Completion Date

March 1, 2015

Completion Date

March 1, 2015

Last Updated

November 2, 2016

Enrollment

604

ACTUAL participants

Conditions

Schizophrenia

Interventions

Placebo

DRUG

bitopertin [RO4917838] level 1

DRUG

bitopertin [RO4917838] level 2

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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