A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder

Schizophrenia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Parallel Arm Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Schizophrenia and Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116830
• Other study ID #: BP22445
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2010
• Last updated: November 1, 2016
• Start date: November 2010
• Est. completion date: February 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 randomized, double-blind, placebo-controlled parallel group study will assess the effect on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of RO4917838 in participants with schizophrenia and schizoaffective disorder. Participants will be randomized to receive either RO4917838 (10 milligrams [mg] daily orally) or placebo for 6 weeks, in addition to their stable antipsychotic medication. Anticipated time on study treatment is 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder (based on screening tests)

• Medically stable for 1 month and psychiatrically stable without symptom exacerbation for 6 weeks prior to baseline

• On stable treatment with a maximum of 2 antipsychotics

Exclusion Criteria:

• Change in regimen for any psychotropic or sleep medication within 1 month

• Treatment with more than (>) 1 mood stabilizer or antidepressant

• Use of clozapine within 2 months

• Bipolar disorder, or more than mild anxiety disorder

Study Design

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizophrenia

Intervention

Drug:
• Placebo
Orally daily for 6 weeks
• RO4917838
10 mg daily orally for 6 weeks
• Standard Antipsychotic Therapy
Participants will continue to receive their current antipsychotic treatment (as they are receiving at the time of screening). Protocol does not specify any particular standard antipsychotic therapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 6, as Measured Using Electroencephalography (EEG)		Baseline, Week 6	No
Primary	Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 6, as Measured Using EEG		Baseline, Week 6	No
Primary	Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 6, as Measured Using EEG		Baseline, Week 6	No
Primary	Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 6, as Measured Using EEG		Baseline, Week 6	No
Primary	Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 6, as Measured Using EEG		Baseline, Week 6	No
Secondary	Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 1, as Measured Using EEG		Baseline, Week 1	No
Secondary	Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 1, as Measured Using EEG		Baseline, Week 1	No
Secondary	Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 1, as Measured Using EEG		Baseline, Week 1	No
Secondary	Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 1, as Measured Using EEG		Baseline, Week 1	No
Secondary	Positive Predictive Value of Cognitive Dysfunction Biomarkers (Mismatch Negativity, ERP, N1 Refractoriness, P3 Component, and VEP) Change at Week 1 to Predict the Presence of Biomarker Response at Week 6, as Measured Using EEG		Baseline, Weeks 1 and 6	No
Secondary	Positive Predictive Value of Cognitive Dysfunction Biomarkers (Mismatch Negativity, ERP, N1 Refractoriness, P3 Component, and VEP) Change at Week 1 to Predict the Change in Symptoms at Week 6, as Measured Using EEG		Baseline, Weeks 1 and 6	No
Secondary	Change From Baseline in Positive and Negative Syndrome Scale Score		Baseline, Weeks 1, 3, and 6	No
Secondary	Change From Baseline in Negative Symptom Assessment Score		Baseline, Weeks 1, 3, and 6	No
Secondary	Change From Baseline in Clinical Global Impression Scale		Baseline, Weeks 1, 3, and 6	No
Secondary	Change From Baseline in Calgary Depression Scale Score		Baseline, Weeks 1, 3, and 6	No
Secondary	Change From Baseline in Global Assessment of Functioning Score		Baseline, Weeks 1, 3, and 6	No
Secondary	Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Battery Score		Baseline, Weeks 1, 3, and 6	No
Secondary	Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 1, as Measured Using EEG		Baseline, Week 1	No