Back to resultsA Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
RO4917838
Standard Antipsychotic Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
RO4917838
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 6, as Measured Using Electroencephalography (EEG)
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 6, as Measured Using EEG
Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 6, as Measured Using EEG
Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 6, as Measured Using EEG
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 6, as Measured Using EEG
Secondary Outcome Measures
Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 1, as Measured Using EEG
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 1, as Measured Using EEG
Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 1, as Measured Using EEG
Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 1, as Measured Using EEG
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
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
Change From Baseline in Positive and Negative Syndrome Scale Score
Change From Baseline in Negative Symptom Assessment Score
Change From Baseline in Clinical Global Impression Scale
Change From Baseline in Calgary Depression Scale Score
Change From Baseline in Global Assessment of Functioning Score
Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Battery Score
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 1, as Measured Using EEG
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01116830
Brief Title
A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
RO4917838
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Orally daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
RO4917838
Intervention Description
10 mg daily orally for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Standard Antipsychotic Therapy
Intervention Description
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 Outcome Measure Information:
Title
Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 6, as Measured Using Electroencephalography (EEG)
Time Frame
Baseline, Week 6
Title
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 6, as Measured Using EEG
Time Frame
Baseline, Week 6
Title
Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 6, as Measured Using EEG
Time Frame
Baseline, Week 6
Title
Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 6, as Measured Using EEG
Time Frame
Baseline, Week 6
Title
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 6, as Measured Using EEG
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 1, as Measured Using EEG
Time Frame
Baseline, Week 1
Title
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 1, as Measured Using EEG
Time Frame
Baseline, Week 1
Title
Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 1, as Measured Using EEG
Time Frame
Baseline, Week 1
Title
Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 1, as Measured Using EEG
Time Frame
Baseline, Week 1
Title
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
Title
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
Title
Change From Baseline in Positive and Negative Syndrome Scale Score
Time Frame
Baseline, Weeks 1, 3, and 6
Title
Change From Baseline in Negative Symptom Assessment Score
Time Frame
Baseline, Weeks 1, 3, and 6
Title
Change From Baseline in Clinical Global Impression Scale
Time Frame
Baseline, Weeks 1, 3, and 6
Title
Change From Baseline in Calgary Depression Scale Score
Time Frame
Baseline, Weeks 1, 3, and 6
Title
Change From Baseline in Global Assessment of Functioning Score
Time Frame
Baseline, Weeks 1, 3, and 6
Title
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
Title
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 1, as Measured Using EEG
Time Frame
Baseline, Week 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28318835
Citation
Kantrowitz JT, Epstein ML, Lee M, Lehrfeld N, Nolan KA, Shope C, Petkova E, Silipo G, Javitt DC. Improvement in mismatch negativity generation during d-serine treatment in schizophrenia: Correlation with symptoms. Schizophr Res. 2018 Jan;191:70-79. doi: 10.1016/j.schres.2017.02.027. Epub 2017 Mar 18.
Results Reference
derived
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A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder
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