ProNET
Research type
Research Study
Full title
Psychosis-Risk Outcome Network (ProNET)
IRAS ID
298487
Contact name
Scott Woods
Contact email
Sponsor organisation
Yale University
Duration of Study in the UK
4 years, 0 months, 30 days
Research summary
Psychotic illness is preceded by a prodromal phase, which represents a key opportunity for preventative interventions. The clinical high risk (CHR) syndrome criteria, which rely on subclinical symptoms of psychosis, were developed two decades ago with the aim of identifying individuals during the prodromal phase of illness and preventing, or at least postponing, the onset of psychosis. As with most psychiatric patients, individuals that meet CHR criteria 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 most daunting obstacle may be the heterogeneity of CHR course. The goal of the ProNET study is to phenotype 1040 CHR patients across the ProNET network of 26 international sites with multi-modal biomarkers, psychopathology and cognition, genetics, body fluid analytes, natural speech/language, and passive/ecological momentary digital phenotyping, and map these biomarkers onto a core set of clinical outcome measures and trajectories over 24 months. The hypothesis is that variation assessed by multivariate neural, genetic, and behavioral measures within the CHR syndrome predicts individualized clinical trajectories, expanding CHR stratification for broad clinical endpoints encompassing affect, anxiety, and cognition with the goal of identifying behavioral and biomarker-driven patterns that can refine the CHR syndrome and promote personalized treatment decisions. These analyses will yield expanded outcome stratification calculators for the CHR syndrome that can predict actionable mental health trajectories in individual patients. The stratification calculators will allow future clinical trial designers to select optimal samples for determining whether a novel compound improves the particular CHR outcome of interest and pave the way for phase-specific and safe new interventions to benefit patients and their families and communities.
The study is sponsored by Yale University. King's College London will act as the UK lead site.REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0381
Date of REC Opinion
24 Mar 2022
REC opinion
Further Information Favourable Opinion