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BEEST: Biomarkers to Enhance Early Schizophrenia Treatment
NCT06969755Phase 4
Key facts
- Status
- Recruiting
- Start
- Sep 2024
- Primary completion
- Jul 2030
- Countries
- 2
- Sponsor
- Northwell Health
- Modality
- Orthosteric Ligands
- Drugs
- clozapine
- Conditions
- schizophreniaschizoaffective disorderschizophreniform disorder
01
Overview
Phase 4, randomised trial of clozapine in schizophrenia, schizoaffective disorder and schizophreniform disorder (3 arms), sponsored by Northwell Health. Primary endpoint: Brief Psychiatric Rating Scale Symptoms at 12 weeks. Started Sep 2024; status: recruiting.
02
Design
3 arms- Study design
- Randomized
risperidone
risperidone treatment provided per protocol
aripiprazole
aripiprazole treatment per protocol
clozapine
clozapine treatment per protocol
03
Who it enrols
Patients aged 18-35 with first-episode psychosis (schizophrenia, schizoaffective, or schizophreniform disorder), moderate to severe positive symptoms, preserved striatal connectivity, and absence of high-risk MC4R and HLA-DQB1 genotypes.
04
Endpoints
Primary
Brief Psychiatric Rating Scale Symptoms
Secondary
Weight Gain
Agranulocytosis
Neutropenia
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