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

Hoffmann-La Roche29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Schizophrenia

Interventions

PlaceboDRUG

Orally daily for 6 weeks

RO4917838DRUG

10 mg daily orally for 6 weeks

Standard Antipsychotic TherapyDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Orangeburg, New York, United States

Outcomes

Primary Outcomes

Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 6, as Measured Using Electroencephalography (EEG)

Time frame: Baseline, Week 6

Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 6, as Measured Using EEG

Time frame: Baseline, Week 6

Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 6, as Measured Using EEG

Time frame: Baseline, Week 6

Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 6, as Measured Using EEG

Time frame: Baseline, Week 6

Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 6, as Measured Using EEG

Time frame: Baseline, Week 6

Secondary Outcomes

Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 1, as Measured Using EEG

Time frame: Baseline, Week 1

Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 1, as Measured Using EEG

Time frame: Baseline, Week 1

Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 1, as Measured Using EEG

Time frame: Baseline, Week 1

Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 1, as Measured Using EEG

Time frame: Baseline, Week 1

Data from ClinicalTrials.gov

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