Accelerating Medicines Partnership® SCHIZOPHRENIA
For Scientists
Using data from a non-interventional study, the Accelerating Medicines Partnership (AMP®) SCZ program seeks to build tools to improve success in developing pharmacologic treatments for patients with clinical high risk for psychosis.

Study Design

This is a non-interventional study examining clinical trajectories and predictors of outcomes in the clinical high risk (CHR) population.

Clinical assessments will be collected monthly for the first year, and then at 18 and 24 months and at the point of conversion to psychosis.

The biomarker measures (imaging, EEG and event-related potentials, fluid-based biomarkers, cognitive assessments, and speech sampling) will be collected at baseline and at two months after study entry. Digital assessments (actigraphy as well phone app-based data collection) will be collected daily for the first year. The collection of these biomarkers over time will validate their use and efficacy in the CHR population to establish early indicators of pharmacologic treatment efficacy.

Cognitive assessments will be collected longitudinally at six, 12 and 24 months and at conversion to psychosis. Unbiased machine language and AI approaches will be used to derive algorithms that predict clinical endpoints: conversion to psychosis (primary clinical endpoint); remission of the CHR state (secondary clinical endpoint), and non-conversion/non-remission (secondary clinical endpoint). These approaches will allow the selection of enriched populations to help improve success in developing pharmacologic treatments.

The goal of AMP® SCZ is to facilitate drug development for the CHR population.

 

Subjects will be monitored over a 24-month period. Measures including structural and functional imaging, electrophysiology, neurocognitive assessments, blood and saliva sampling, and speech sampling will be collected at baseline (month 0) and a second timepoint approximately 2 months later. These will be the primary data collection points that will be used to inform prediction of conversion to psychosis. Additional subsequent data collection will be used for monitoring.

Young people who are identified as being at risk for developing psychosis may experience different clinical trajectories including diagnosis of psychotic disorder, other psychiatric illnesses or symptom remission. We will use a "deep phenotyping" approach to help predict who is likely to progress to clinical states (conversion, remission, non-conversion/non-remission). Clinical, cognitive, brain imaging, electrophysiology, blood and saliva, speech sampling and digital measures will be used to build predictive models to help answer this question.

 

 


Last Reviewed on December 20, 2022