A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)

Schizophrenia Clinical Trial

Official title:

A Phase III, Multi-center, Randomized, 24 Week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-blind Treatment Period.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192906
• Other study ID #: WN25309
• Secondary ID: 2010-020467-21
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2010
• Last updated: November 1, 2016
• Start date: December 2010
• Est. completion date: July 2014

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 multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with persistent, predominant negative 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: 624
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, aged 18 years and above

• Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype

• Predominant negative symptoms

• With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)

Exclusion Criteria:

• Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)

• Body Mass Index (BMI) of <17 or >40 kg/m2

• Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)

• A severity score of 3 or greater on the Parkinsonism item of the ESRS-A (Clinical Global Impression, Parkinsonism)

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]
Oral dose level 1, once a day for 52 weeks
• bitopertin [RO4917838]
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,  Brazil,  Canada,  Chile,  Germany,  Latvia,  Lithuania,  Netherlands,  Poland,  Slovakia,  Spain,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (PANSS negative symptoms factor score)		Week 24	No
Primary	Safety (incidence of adverse events)		Week 24	No