AMP SCZ® Observational Study: PREDICT-DPACC

Description

The Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) is a large international collaboration to develop algorithms using a set of clinical and cognitive assessments, multi-modal biomarkers, and clinical endpoints that can be used to predict the trajectories and outcomes of individuals at clinical high risk (CHR) for psychosis and to advance the testing of pharmacological interventions for CHR individuals in need. The goal is to accurately predict which individuals are likely to remit, experience an acute psychotic episode, or have intermediate outcomes that feature persistent attenuated psychotic and/or mood symptoms along with functional impairment. The prediction algorithms will have the potential to serve as early indicators of treatment efficacy in CHR persons. The AMP SCZ research program is made up of the Psychosis Risk Evaluation, Data Integration, and Computational Technologies - Data Processing, Analysis and Coordination Center (PREDICT-DPACC) and two clinical research networks, the Psychosis-Risk Outcomes Network (ProNET) and the Trajectories and Predictors in the Clinical High Risk for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT) networks. The two clinical research networks will recruit a large cohort of CHR young people aged 12-30 years (n=1,977) and healthy control (HC) participants (n=640) across 42 participating investigative sites from 13 countries. CHR participants will complete screening, baseline assessments and a battery of follow-up assessments across 18 - 24 months. HC participants will complete screening and baseline assessments and a subset (5 per site) will complete month 2, 12 and 24 visits.

Conditions

Clinical High Risk, Psychosis, Remission, Conversion

Study Overview

Study Details

Study overview

The Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) is a large international collaboration to develop algorithms using a set of clinical and cognitive assessments, multi-modal biomarkers, and clinical endpoints that can be used to predict the trajectories and outcomes of individuals at clinical high risk (CHR) for psychosis and to advance the testing of pharmacological interventions for CHR individuals in need. The goal is to accurately predict which individuals are likely to remit, experience an acute psychotic episode, or have intermediate outcomes that feature persistent attenuated psychotic and/or mood symptoms along with functional impairment. The prediction algorithms will have the potential to serve as early indicators of treatment efficacy in CHR persons. The AMP SCZ research program is made up of the Psychosis Risk Evaluation, Data Integration, and Computational Technologies - Data Processing, Analysis and Coordination Center (PREDICT-DPACC) and two clinical research networks, the Psychosis-Risk Outcomes Network (ProNET) and the Trajectories and Predictors in the Clinical High Risk for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT) networks. The two clinical research networks will recruit a large cohort of CHR young people aged 12-30 years (n=1,977) and healthy control (HC) participants (n=640) across 42 participating investigative sites from 13 countries. CHR participants will complete screening, baseline assessments and a battery of follow-up assessments across 18 - 24 months. HC participants will complete screening and baseline assessments and a subset (5 per site) will complete month 2, 12 and 24 visits.

Accelerating Medicines Partnership® Schizophrenia Observational Study: Psychosis Risk Evaluation, Data Integration, and Computational Technologies -Data Processing, Analysis, and Coordination Center and Coordination Center

AMP SCZ® Observational Study: PREDICT-DPACC

Condition
Clinical High Risk
Intervention / Treatment

-

Contacts and Locations

Irvine

University of California Irvine, Irvine, California, United States, 92697

Los Angeles

University of California Los Angeles, Los Angeles, California, United States, 90095,

San Diego

University of California San Diego, San Diego, California, United States, 92103

San Francisco

University of California San Francisco, San Francisco, California, United States, 94121

Hartford

Hartford Healthcare, Hartford, Connecticut, United States, 06106

New Haven

Yale University/Connecticut Mental Health Center, New Haven, Connecticut, United States, 06519

Athens

University of Georgia, Athens, Georgia, United States, 30602

Evanston

Northwestern University, Evanston, Illinois, United States, 60201

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02115

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Individuals between 12 and 30 years old;
  • * Understand and sign an informed consent (or assent for minors) document;
  • * Meet diagnostic criteria for CHR from the Positive SYmptoms and Diagnostic Criteria for the CAARMS Harmonized with the SIPS (PSYCHS).
  • * Antipsychotic medication exposure equivalent to a total lifetime haloperidol dose of \>50 mg or current antipsychotic medication at time of screening assessment;
  • * Documented history of intellectual disability;
  • * Past or current clinically relevant central nervous system disorder;
  • * Traumatic brain injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument;
  • * Current or past treated or untreated psychotic episode, as determined using the PSYCHS.

Ages Eligible for Study

12 Years to 30 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Brigham and Women's Hospital,

Martha E Shenton, Ph.D., PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital/Harvard Medical School

Scott Woods, M.D., PRINCIPAL_INVESTIGATOR, Yale University

Barnaby Nelson, Ph.D., PRINCIPAL_INVESTIGATOR, Center for Youth Mental Health at the University of Melbourne/Orygen

Study Record Dates

2025-05-31