A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: bitopertin [RO4917838] level 2; Drug: bitopertin [RO4917838] level 1; Drug: Placebo

• Registration Number: NCT01235559
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-05
• Study Start: 2010-12
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Disposition First Submitted: 2016-07-06
• Disposition First Submitted QC: 2016-07-06
• Disposition First Posted: 2016-07-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 604

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)

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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"

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bitopertin [RO4917838] 2	bitopertin [RO4917838] level 2	-
bitopertin [RO4917838] 1	bitopertin [RO4917838] level 1	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety (incidence of adverse events)	Week 12
Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)	Change from baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
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