A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)

This study is currently recruiting participants.

Verified January 2013 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01235585

First received: October 22, 2010

Last updated: January 14, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 22, 2010

Last Updated Date

January 14, 2013

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Change from baseline to Week 12 ] [ Designated as safety issue: No ]
Safety (incidence of adverse events) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01235585 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Change from baseline to Week 12 ] [ Designated as safety issue: No ]
Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale [ Time Frame: Change from baseline to Week 12 ] [ Designated as safety issue: No ]
Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale [ Time Frame: Change from baseline to Week 12 ] [ Designated as safety issue: No ]
Safety (incidence of adverse events) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)

Official Title ^ICMJE

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.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: bitopertin [RO4917838]
Oral dose level 1, once a day for 52 weeks
Drug: bitopertin [RO4917838]
Oral dose level 2, once a day for 52 weeks
Drug: Placebo
Oral doses, once a day for 52 weeks

Study Arm (s)

Experimental: 1
Intervention: Drug: bitopertin [RO4917838]
Experimental: 2
Intervention: Drug: bitopertin [RO4917838]
Placebo Comparator: 3
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

February 2014

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patients, >/= 18 years of age
Diagnosis of schizophrenia
Clinical stability for 12 weeks prior to screening period
Antipsychotic treatment stability for 8 weeks prior to screening period
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 anorexia or obesity (body mass index (BMI) <18.5 or >40, respectively)
Diagnosis of mental retardation or severe organic brain syndromes
In the investigator's judgment, a significant risk of suicide or violent behavior

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: WN25306 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

United States, Brazil, Canada, Chile, Germany, Latvia, Lithuania, Netherlands, Poland, Slovakia, Spain, Taiwan, Turkey, Ukraine

Administrative Information

NCT Number ^ICMJE

NCT01235585

Other Study ID Numbers ^ICMJE

WN25306, 2010-020616-11

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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