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

Status:	Completed
Conditions:	Schizophrenia
Therapuetic Areas:	Psychiatry / Psychology
Healthy:	No
Age Range:	18 - Any
Updated:	8/3/2016
Start Date:	December 2010
End Date:	July 2014

A Phase III, Multi-center, Randomized, 24 Week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-blind Treatment Period.

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.

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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)

We found this trial at

sites

Clinical Trial Facility in Rochester New York

Rochester, New York

from

Rochester, NY