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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01116830
First received: May 4, 2010
Last updated: November 1, 2016
Last verified: November 2016

May 4, 2010
November 1, 2016
November 2010
February 2014   (final data collection date for primary outcome measure)
  • Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 6, as Measured Using Electroencephalography (EEG) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 6, as Measured Using EEG [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 6, as Measured Using EEG [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 6, as Measured Using EEG [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 6, as Measured Using EEG [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
Change in biomarker measures of cognitive dysfunction [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01116830 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 1, as Measured Using EEG [ Time Frame: Baseline, Week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 1, as Measured Using EEG [ Time Frame: Baseline, Week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 1, as Measured Using EEG [ Time Frame: Baseline, Week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 1, as Measured Using EEG [ Time Frame: Baseline, Week 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline in Positive and Negative Syndrome Scale Score [ Time Frame: Baseline, Weeks 1, 3, and 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Negative Symptom Assessment Score [ Time Frame: Baseline, Weeks 1, 3, and 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Clinical Global Impression Scale [ Time Frame: Baseline, Weeks 1, 3, and 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Calgary Depression Scale Score [ Time Frame: Baseline, Weeks 1, 3, and 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Global Assessment of Functioning Score [ Time Frame: Baseline, Weeks 1, 3, and 6 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 1, as Measured Using EEG [ Time Frame: Baseline, Week 1 ] [ Designated as safety issue: No ]
  • Change in biomarker measures of cognitive dysfunction [ Time Frame: after 1 week of treatment ] [ Designated as safety issue: No ]
  • Predictive value of biomarker changes after 1 week for biomarker responses after 6 weeks [ Time Frame: 1 and 6 weeks ] [ Designated as safety issue: No ]
  • Predictive value of biomarker changes on changes in symptoms [ Time Frame: 1 and 6 weeks ] [ Designated as safety issue: No ]
  • Clinical efficacy (PANSS, NSA, CDS, CGI scales, MATRICS battery) [ Time Frame: weeks 1, 3 and 6 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • 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.
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Drug: Standard Antipsychotic Therapy
  • Experimental: RO4917838
    Interventions:
    • Drug: RO4917838
    • Drug: Standard Antipsychotic Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01116830
BP22445
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP