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A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)

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.

NCT01235520•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 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 (121)

Little Rock, Arkansas, United States

Buena Park, California, United States

Cerritos, California, United States

Downey, California, United States

La Palma, California, United States

Pasadena, California, United States

Pico Rivera, California, United States

Miami, Florida, United States

Key Dates

Start Date

January 1, 2011

Primary Completion Date

July 1, 2014

Completion Date

July 1, 2014

Last Updated

June 2, 2015

Enrollment

595

ACTUAL participants

Conditions

Schizophrenia

Interventions

Placebo

DRUG

RO4917838

DRUG

RO4917838

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: June 2, 2015Data 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 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)

Inclusion Criteria

Exclusion Criteria

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

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

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