Phase III, Multi-center, Randomized, 12-week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 40-week Double-blind, Parallel-group, Placebo-controlled Treatment Period.

Hoffmann-La Roche0 sites604 target enrollmentDecember 2010

ConditionsSchizophrenia

InterventionsPlacebo bitopertin [RO4917838] level 1 bitopertin [RO4917838] level 2

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Schizophrenia
Sponsor: Hoffmann-La Roche
Enrollment: 604
Primary Endpoint: Safety (incidence of adverse events)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

March 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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)

Exclusion Criteria

•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"

Arms & Interventions

Placebo

Intervention: Placebo

bitopertin [RO4917838] 1

Intervention: bitopertin [RO4917838] level 1

bitopertin [RO4917838] 2

Intervention: bitopertin [RO4917838] level 2

Outcomes

Primary Outcomes

Safety (incidence of adverse events)

Time Frame: Week 12

Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)

Time Frame: Change from baseline to Week 12

Secondary Outcomes

Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)(Change from baseline to Week 12)
Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale(Change from baseline to Week 12)
Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale(Change from baseline to Week 12)
Safety (incidence of adverse events)(60 weeks)