Biomarkers to Enhance Early Schizophrenia Treatment
Northwell Health
Summary
This study is recruiting participants who are experiencing a first episode of psychosis and who have certain genetic factors that may make them respond better to certain medications that are used to treat people with psychosis.
Description
The study is designed to test the hypothesis that, compared with standard treatment with FL-APs (risperidone or aripiprazole), early treatment with clozapine (CLZ) will benefit patients in the first episode of psychosis (FEP) who have been designated three biomarker positive (3B+) as follows: 1) likely to have a poor response to FL-APs; 2) not at heightened risk for clozapine-induced agranulocytosis and 3) not at heightened risk for antipsychotic-induced weight gain. The study will recruit n=410 FEP across the 5 participating sites for screening on each of the 3 biomarkers (striatal connectivi…
Eligibility
- Age range
- 18–35 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Aged 18 to 35. 2. DSM5 diagnosis (as determined by the SCID5) of schizophrenia, schizoaffective disorder, schizophreniform disorder. 3. Current positive symptoms rated ≥4 (moderate) on one or more of the following BPRS positive subscale items: unusual thought content, conceptual disorganization, hallucinatory behavior, suspiciousness. 4. Preserved striatal connectivity, as determined by screening MRI scan 5. Absence of the MC4R high-risk genotype, as determined by genetic testing 6. Absence of the HLA-DQB1 high-risk genotype, as determined by genetic testing 7. In an ea…
Interventions
- Drugaripiprazole
aripiprazole arm (titrated dose)
- Drugrisperidone
risperidone arm (titrated dose)
- Drugclozapine
clozapine (titrated dose)
Locations (2)
- Feinstein Institute for Medical ResearchGlen Oaks, New York
- Centre for Addiction and Mental HealthToronto