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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2014

Interventions

  • Drug: Placebo
    • Orally daily for 6 weeks
  • Drug: RO4917838
    • 10 mg daily orally for 6 weeks
  • Drug: 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.

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
  • Experimental: RO4917838

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
    • Time Frame: 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
    • Time Frame: Baseline, Weeks 1 and 6
  • Change From Baseline in Positive and Negative Syndrome Scale Score
    • Time Frame: Baseline, Weeks 1, 3, and 6
  • Change From Baseline in Negative Symptom Assessment Score
    • Time Frame: Baseline, Weeks 1, 3, and 6
  • Change From Baseline in Clinical Global Impression Scale
    • Time Frame: Baseline, Weeks 1, 3, and 6
  • Change From Baseline in Calgary Depression Scale Score
    • Time Frame: Baseline, Weeks 1, 3, and 6
  • Change From Baseline in Global Assessment of Functioning Score
    • Time Frame: Baseline, Weeks 1, 3, and 6
  • Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Battery Score
    • Time Frame: Baseline, Weeks 1, 3, and 6
  • Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 1, as Measured Using EEG
    • Time Frame: Baseline, Week 1

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche

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