A Phase II, Multi-center, Randomized, 4-week, Double-blind, Parallel Group, Placebo and Active-controlled Trial of the Safety and Efficacy of RO4917838 vs. Placebo in Patients With an Acute Exacerbation of Schizophrenia

Hoffmann-La Roche0 sites301 target enrollmentFebruary 2011

ConditionsSchizophrenia

Interventionsbitopertin [RO4917838]olanzapine placebo

Drugsbitopertin [RO4917838]olanzapine placebo

Overview

Phase: Phase 2
Intervention: bitopertin [RO4917838]
Conditions: Schizophrenia
Sponsor: Hoffmann-La Roche
Enrollment: 301
Primary Endpoint: Safety: Incidence adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This randomized, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients, with a 4-week follow-up period.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

September 2012

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, 18-65 years of age
•Diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders DSM IV-TR)
•Acute exacerbation which began within the prior 8 weeks
•Female patients must be surgically sterile or post-menopausal, or agree to use effective contraception for the duration of the study

Exclusion Criteria

•Current psychiatric diagnosis other than schizophrenia
•Alcohol or substance dependence within 3 months or abuse within 1 month (except for nicotine)
•Electro-convulsive therapy (ECT) within the prior 6 months
•Previous treatment with RO4917838 or another GLYT inhibitor
•Current treatment with olanzapine, or previous treatment with intolerability or lack of response
•Treatment with long-acting injectable antipsychotic within 2 dosing intervals
•Treatment with \> 2 antipsychotics within 3 months
•History of neuroleptic malignant syndrome
•Have treatment-resistant schizophrenia as judged by treating physician or have failed two trials according to criteria in protocol

Arms & Interventions

A

Intervention: bitopertin [RO4917838]

B

Intervention: bitopertin [RO4917838]

C

Intervention: olanzapine

D

Intervention: placebo

Outcomes

Primary Outcomes

Safety: Incidence adverse events

Time Frame: 8 weeks

Change in Positive and Negative Syndrome Scale (PANSS) total score

Time Frame: from baseline to Day 28

Secondary Outcomes

Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale(from baseline to Day 28)
Change in symptomatology as measured by the PANSS factor and subscale scores(from baseline to Day 28)
Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE)(from baseline to Day 28)
Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score(from baseline to Day 28)
Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale(from baseline to Day 28)
Time to readiness for discharge from inpatient unit as assessed by the Readiness For Hospital Discharge Questionnaire (RDQ)(from baseline to Day 28)