NIH-funded research R01 grant

Using biomarkers to guide early schizophrenia care

Official title: 1/5 Biomarkers to Enhance Early Schizophrenia Treatment (BEEST)

Funded at Centre for Addiction and Mental Health · NIH-11184377 · Data updated 2026-11-12

This project uses brain scans and simple genetic tests to help doctors decide sooner if young people (ages 12–20) with a first episode of psychosis should switch to clozapine.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionCentre for Addiction and Mental Health
NIH-funded
Lab location1 site (Toronto, Canada)
Project startSeptember 5, 2024
Project endJuly 31, 2029
Funding year2025
Award (this year)$289,958
NIH project number5R01MH134889-02
Project IDNIH-11184377 on NIH RePORTER

Who could benefit from this research

Could help

Young people (roughly ages 12–20) experiencing a first episode of psychosis who are starting or not responding to first-line antipsychotics are the ideal candidates for this project.

Less likely to help

People without a first episode of psychosis, older adults, those already stable on their current antipsychotic, or anyone unwilling to have MRI scans, genetic testing, or clozapine blood monitoring are unlikely to benefit from participating.

What this research studies

If you are a young person who just had a first episode of psychosis, the team will collect three biomarkers including a resting-state brain scan and a genetic test to learn who is unlikely to respond to first-line antipsychotics and who is at lower risk for side effects. About 410 participants across multiple centers will be enrolled and randomly assigned to receive biomarker-informed recommendations or usual care. Researchers will follow symptoms, weight changes, and blood counts over time and use those data to build a clozapine decision support tool. The study includes safety monitoring for clozapine-related risks such as agranulocytosis.

Why it matters

Potential benefit: If successful, this approach could shorten delays to the most effective medication for people who need clozapine and reduce years of ineffective treatment and disability.

How similar studies have gone: Smaller prior studies by this team and others suggest resting-state fMRI and genetic markers can predict treatment response and side-effect risk, but using them in a randomized, multi-center clozapine decision trial is a new, larger step.

Where this research is happening

  • Centre for Addiction and Mental Health
    Toronto, Canada
    Active

Researchers

  • Principal investigator: Voineskos, Aristotle Nicholas — Centre for Addiction and Mental Health
  • Study coordinator: Voineskos, Aristotle Nicholas

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.