A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: bitopertin [RO4917838]; Drug: olanzapine; Drug: placebo

• Registration Number: NCT01234779
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Study Start: 2011-02
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Disposition First Submitted: 2013-10-07
• Disposition First Submitted QC: 2013-10-07
• Disposition First Posted: 2013-10-30
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	bitopertin [RO4917838]	-
C	olanzapine	-
B	bitopertin [RO4917838]	-
D	placebo	-

Primary Outcome Measures

Name	Time	Method
Safety: Incidence adverse events	8 weeks
Change in Positive and Negative Syndrome Scale (PANSS) total score	from baseline to Day 28

Secondary Outcome Measures

Name	Time	Method
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