Biomarkers to Guide Early Clozapine Use in First-Episode Psychosis
Official title: 2/5-Biomarkers to Enhance Early Schizophrenia Treatment (BEEST)
Funded at Feinstein Institute for Medical Research · NIH-11394523 · Data updated 2026-11-12
This grant tests whether brain scans and a simple genetic test can help doctors decide earlier if a patient with a first-episode psychosis should switch to Clozapine to improve outcomes.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Feinstein Institute for Medical Research NIH-funded |
| Lab location | 1 site (Manhasset, United States) |
| Project start | September 5, 2024 |
| Project end | July 31, 2029 |
| Funding year | 2026 |
| Award (this year) | $630,879 |
| NIH project number | 5R01MH134883-03 |
| Project ID | NIH-11394523 on NIH RePORTER |
Who could benefit from this research
✓Could help
Young people (typically late adolescence to early adulthood) experiencing a first episode of psychosis who may need antipsychotic treatment and are open to biomarker-guided care.
✕Less likely to help
Patients unlikely to experience benefit are those for whom biomarkers do not predict treatment response or who cannot participate in imaging or genetic testing.
What this research studies
In teens and young adults experiencing a first psychotic episode, getting the right treatment quickly is crucial. The study aims to use biomarkers from brain imaging and genetics to predict who will not respond to first-line antipsychotics and who might be protected from major side effects like weight gain or agranulocytosis. It will involve multiple centers and a randomized design to develop a Clozapine decision-support tool based on these biomarkers. Participants will undergo biomarker assessments and receive tailored treatment guidance to see if outcomes improve. The ultimate goal is to provide clinicians with a validated tool to personalize therapy in early psychosis.
Why it matters
Potential benefit: If successful, patients could receive faster, more targeted treatment, potentially improving symptom control and reducing risky side effects.
How similar studies have gone: Initial work suggests that brain imaging and genetics can help predict treatment response and side effects, with further validation needed in diverse centers.
Where this research is happening
-
Feinstein Institute for Medical Research
Manhasset, United States Active
Researchers
- Principal investigator: Malhotra, Anil K — Feinstein Institute for Medical Research
- Study coordinator: Malhotra, Anil K
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.