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

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 (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.

Key facts

Study ID

NCT01235559

Run by

Hoffmann-La Roche

People needed

604

Starts

2010-12-01

Expected to finish

2015-03-01

Last updated by the study team

2016-11-02

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 — Escondido, California, United States
• Study site — Granada Hills, California, United States
• Study site — La Jolla, California, United States
• Study site — Oceanside, California, United States
• Study site — San Diego, California, United States
• Study site — Torrance, California, United States
• Study site — Lauderhill, Florida, United States
• Study site — Orange City, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Flowood, Mississippi, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Scranton, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — Irving, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Burgas, Bulgaria
• Study site — Kazanlak, Bulgaria
• Study site — Novi Iskar, Bulgaria
• Study site — Costa Mesa, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.