A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

This multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with persistent, predominant negative 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

NCT01192906

Run by

Hoffmann-La Roche

People needed

624

Starts

2010-12-01

Expected to finish

2014-07-01

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, aged 18 years and above
• Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
• Predominant negative symptoms
• With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)

You may not qualify if…

• Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
• Body Mass Index (BMI) of <17 or >40 kg/m2
• Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)
• A severity score of 3 or greater on the Parkinsonism item of the ESRS-A (Clinical Global Impression, Parkinsonism)

Where it is running

• Study site — Oceanside, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Hartford, Connecticut, United States
• Study site — Norwalk, Connecticut, United States
• Study site — North Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Hoffman Estates, Illinois, United States
• Study site — Joliet, Illinois, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — St Louis, Missouri, United States
• Study site — Omahac, Nebraska, United States
• Study site — Cedarhurst, New York, United States
• Study site — Jamaica, New York, United States
• Study site — Rochester, New York, United States
• Study site — Allentown, Pennsylvania, United States
• Study site — Norristown, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Salvador, Estado de Bahia, Brazil
• Study site — Goiânia, Goiás, Brazil
• Study site — Belo Horizonte, Minas Gerais, Brazil
• Study site — Curitiba, Paraná, Brazil
• Study site — Carson, 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.