AMP SCZ® Observational Study: PREDICT-DPACC

Summary

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

Sponsors & Collaborators

• Orygen

  collaborator OTHER

• Yale University

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

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

• Scott Woods, M.D. · Yale University

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

Eligibility

Min Age

12 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-02

Primary Completion

2027-04-30

Completion

2027-04-30

Countries

• United States
• Australia
• Canada
• Chile
• China
• Denmark
• Germany
• Hong Kong
• Italy
• Singapore
• South Korea
• Spain
• Switzerland
• United Kingdom

Study Locations