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Completed

NCT Number: NCT01116830

A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orangeburg, New York, 10962, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Orally daily for 6 weeks

RO4917838

Drug

10 mg daily orally for 6 weeks

Standard Antipsychotic Therapy

Drug

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.

Primary outcomes

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

    Time frame: Baseline, Week 6

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

    Time frame: Baseline, Week 6

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

    Time frame: Baseline, Week 6

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

    Time frame: Baseline, Week 6

  5. 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

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

    Time frame: Baseline, Week 1

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

    Time frame: Baseline, Week 1

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

    Time frame: Baseline, Week 1

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

    Time frame: Baseline, Week 1

  5. 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

  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

  7. Change From Baseline in Positive and Negative Syndrome Scale Score

    Time frame: Baseline, Weeks 1, 3, and 6

  8. Change From Baseline in Negative Symptom Assessment Score

    Time frame: Baseline, Weeks 1, 3, and 6

  9. Change From Baseline in Clinical Global Impression Scale

    Time frame: Baseline, Weeks 1, 3, and 6

  10. Change From Baseline in Calgary Depression Scale Score

    Time frame: Baseline, Weeks 1, 3, and 6

  11. Change From Baseline in Global Assessment of Functioning Score

    Time frame: Baseline, Weeks 1, 3, and 6

  12. 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

  13. Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 1, as Measured Using EEG

    Time frame: Baseline, Week 1

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 5, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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