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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Schizophrenia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 29
- Primary Endpoint
- Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 6, as Measured Using Electroencephalography (EEG)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Placebo
Intervention: Placebo
Placebo
Intervention: Standard Antipsychotic Therapy
RO4917838
Intervention: RO4917838
RO4917838
Intervention: Standard Antipsychotic Therapy
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(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)