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

Schizophrenia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235559
• Other study ID #: WN25305
• Secondary ID: 2010-020718-26
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2010
• Last updated: November 1, 2016
• Start date: December 2010
• Est. completion date: March 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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"

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Bulgaria,  China,  Czech Republic,  Italy,  Japan,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)		Change from baseline to Week 12	No
Primary	Safety (incidence of adverse events)		Week 12	No
Secondary	Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)		Change from baseline to Week 12	No
Secondary	Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale		Change from baseline to Week 12	No
Secondary	Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale		Change from baseline to Week 12	No
Secondary	Safety (incidence of adverse events)		60 weeks	No