Clinical trial NCT01116830: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-05-05
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 6, as Measured Using Electroencephalography (EEG)
timeFrame: Baseline, Week 6
measure: Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 6, as Measured Using EEG
timeFrame: Baseline, Week 6
measure: Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 6, as Measured Using EEG
timeFrame: Baseline, Week 6
measure: Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 6, as Measured Using EEG
timeFrame: Baseline, Week 6
measure: Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 6, as Measured Using EEG
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 1, as Measured Using EEG
timeFrame: Baseline, Week 1
measure: Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 1, as Measured Using EEG
timeFrame: Baseline, Week 1
measure: Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 1, as Measured Using EEG
timeFrame: Baseline, Week 1
measure: Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 1, as Measured Using EEG
timeFrame: Baseline, Week 1
measure: 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
timeFrame: Baseline, Weeks 1 and 6
measure: 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
timeFrame: Baseline, Weeks 1 and 6
measure: Change From Baseline in Positive and Negative Syndrome Scale Score
timeFrame: Baseline, Weeks 1, 3, and 6
measure: Change From Baseline in Negative Symptom Assessment Score
timeFrame: Baseline, Weeks 1, 3, and 6
measure: Change From Baseline in Clinical Global Impression Scale
timeFrame: Baseline, Weeks 1, 3, and 6
measure: Change From Baseline in Calgary Depression Scale Score
timeFrame: Baseline, Weeks 1, 3, and 6
measure: Change From Baseline in Global Assessment of Functioning Score
timeFrame: Baseline, Weeks 1, 3, and 6
measure: Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Battery Score
timeFrame: Baseline, Weeks 1, 3, and 6
measure: Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 1, as Measured Using EEG
timeFrame: Baseline, Week 1
Other outcomes:
Locations:
city: Orangeburg
country: United States
state: New York
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.