# ProCAN: Psychosis Risk Outcomes Compound Assessment Network

> **NIH NIH U01** · YALE UNIVERSITY · 2024 · $14,993,866

## Abstract

PROJECT SUMMARY
 It has now been two decades since the clinical high risk for psychosis (CHR) criteria were first
formulated in service of the goal of preventing psychotic disorders, one of the most urgent unmet clinical
needs in behavioral health if not in all of medicine. As with most psychiatric patients, CHR patients benefit
from psychotherapies but are also often left with important treatment needs not fully addressed. Despite
the critical public health need, drug development for CHR is viewed in many quarters as risky. The
Foundation for the National Institutes of Health and the National Institute of Mental Health along with other
public and private partners established the Psychosis Risk Outcomes Network (ProNET) and the
Accelerating Medicines Partnership® Schizophrenia Observational Study (AMP® SCZ) in 2020 to develop
tools to parse the heterogeneity of the CHR syndrome and de-risk the drug development that could lead
to improvement of symptoms and functioning in CHR patients and ultimately to the prevention of
schizophrenia. The current project, the Psychosis Risk Outcomes Compound Assessment Network
(ProCAN), follows up on this successful previous initiative and will establish infrastructure to determine, in
partnership with the Clinical Trials Data Processing Analysis and Coordination Center (CT-DPACC),
whether the biological, digital, cognitive, and clinical outcome measures developed in AMP SCZ are
viable as drug development tools (DDTs) for use in Phase 2 clinical trials in participants at clinical high
risk for psychosis (CHR). One or two Phase 2-ready compounds will be studied, each selected by the
AMP SCZ Compound Selection Committee. Aim 1 will evaluate the potential of selected compound(s) to
detect a signal in CHR participants on one or more biological, digital, cognitive, or clinical outcome
measures developed in the AMP SCZ Observational Study within a 16 week time frame. We propose two
trials, each with 15 sites, each with three arms and 65 participants per arm (total per trial N=195), and
each with the Network RFA specified maximum 16 week follow-up. Compound safety will also be
evaluated. Aim 2 will determine whether biomarkers developed in the AMP SCZ Observational Study
and/or novel biomarkers can act as pharmacodynamic readouts of drug response and/or provide insights
into proposed mechanisms or pathways underlying CHR for psychosis. We propose biomarker timepoints
at baseline and 8 and 16 weeks. If outcome or biomarker signals are detected, findings will pave the way
for further development of phase-specific and safe new interventions to benefit CHR patients and their
families and communities.

## Key facts

- **NIH application ID:** 10954120
- **Project number:** 1U01MH137298-01
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** CARRIE E BEARDEN
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $14,993,866
- **Award type:** 1
- **Project period:** 2024-06-14 → 2029-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10954120

## Citation

> US National Institutes of Health, RePORTER application 10954120, ProCAN: Psychosis Risk Outcomes Compound Assessment Network (1U01MH137298-01). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10954120. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*