Schizophrenia
Conditions
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.
Interventions
DRUGPlacebo
Orally daily for 6 weeks
DRUGRO4917838
10 mg daily orally for 6 weeks
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 6, as Measured Using Electroencephalography (EEG) | Baseline, Week 6 |
| Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 6, as Measured Using EEG | Baseline, Week 6 |
| Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 6, as Measured Using EEG | Baseline, Week 6 |
| Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 6, as Measured Using EEG | Baseline, Week 6 |
| Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 6, as Measured Using EEG | Baseline, Week 6 |
Secondary
| Measure | Time frame |
|---|---|
| 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 | Baseline, Weeks 1 and 6 |
| Change From Baseline in Positive and Negative Syndrome Scale Score | Baseline, Weeks 1, 3, and 6 |
| Change From Baseline in Negative Symptom Assessment Score | Baseline, Weeks 1, 3, and 6 |
| Change From Baseline in Clinical Global Impression Scale | Baseline, Weeks 1, 3, and 6 |
| Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 1, as Measured Using EEG | Baseline, Week 1 |
| Change From Baseline in Global Assessment of Functioning Score | Baseline, Weeks 1, 3, and 6 |
| Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Battery Score | Baseline, Weeks 1, 3, and 6 |
| Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 1, as Measured Using EEG | Baseline, Week 1 |
| Change From Baseline in Calgary Depression Scale Score | Baseline, Weeks 1, 3, and 6 |
| Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 1, as Measured Using EEG | Baseline, Week 1 |
| Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 1, as Measured Using EEG | Baseline, Week 1 |
| Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 1, as Measured Using EEG | Baseline, Week 1 |
| 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 | Baseline, Weeks 1 and 6 |
Countries
United States
Outcome results
None listed