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

Roche

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: bitopertin [RO4917838]

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01192906

WN25309

2010-020467-21

Details and patient eligibility

About

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.

Enrollment

624 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)