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

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01235520

Run by

Hoffmann-La Roche

People needed

595

Starts

2011-01-01

Expected to finish

2014-07-01

Last updated by the study team

2015-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Buena Park, California, United States
• Study site — Cerritos, California, United States
• Study site — Downey, California, United States
• Study site — La Palma, California, United States
• Study site — Pasadena, California, United States
• Study site — Pico Rivera, California, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Oak Brook, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Glen Burnie, Maryland, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Toms River, New Jersey, United States
• Study site — Willingboro, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Brooklyn, New York, United States
• Study site — Fresh Meadows, New York, United States
• Study site — New York, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Scranton, Pennsylvania, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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