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

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: RO4917838; Drug: Standard Antipsychotic Therapy

• Registration Number: NCT01116830
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Study Start: 2010-11
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Placebo	Standard Antipsychotic Therapy	-
RO4917838	RO4917838	-
RO4917838	Standard Antipsychotic Therapy	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 6, as Measured Using Electroencephalography (EEG)	Baseline, Week 6
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 6, as Measured Using EEG	Baseline, Week 6
Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 6, as Measured Using EEG	Baseline, Week 6
Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 6, as Measured Using EEG	Baseline, Week 6
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 6, as Measured Using EEG	Baseline, Week 6

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 1, as Measured Using EEG	Baseline, Week 1
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 1, as Measured Using EEG	Baseline, Week 1
Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 1, as Measured Using EEG	Baseline, Week 1
Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 1, as Measured Using EEG	Baseline, Week 1
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
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
Change From Baseline in Positive and Negative Syndrome Scale Score	Baseline, Weeks 1, 3, and 6
Change From Baseline in Negative Symptom Assessment Score	Baseline, Weeks 1, 3, and 6
Change From Baseline in Clinical Global Impression Scale	Baseline, Weeks 1, 3, and 6
Change From Baseline in Calgary Depression Scale Score	Baseline, Weeks 1, 3, and 6
Change From Baseline in Global Assessment of Functioning Score	Baseline, Weeks 1, 3, and 6
Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Battery Score	Baseline, Weeks 1, 3, and 6
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 1, as Measured Using EEG	Baseline, Week 1