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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: September 1, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Schizophrenia
Drug: Placebo
Drug: RO4917838
Drug: Standard Antipsychotic Therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 29
Study Start Date: November 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Orally daily 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.
Experimental: RO4917838 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116830

Locations
United States, New York
Orangeburg, New York, United States, 10962
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01116830     History of Changes
Other Study ID Numbers: BP22445 
Study First Received: May 4, 2010
Last Updated: September 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 30, 2016