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NCT05905003

AMP SCZ® Observational Study: PREDICT-DPACC

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - 30 Years

Study Type

OBSERVATIONAL

Enrollment

2617

Start Date

2022-06-02

Completion Date

2027-04-30

Last Updated

2025-10-31

Healthy Volunteers

Yes

Locations (42)

University of California Irvine

Irvine, California, United States

University of California Los Angeles

Los Angeles, California, United States

University of California San Diego

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

Hartford Healthcare

Hartford, Connecticut, United States

Yale University/Connecticut Mental Health Center

New Haven, Connecticut, United States

University of Georgia

Athens, Georgia, United States

Northwestern University

Evanston, Illinois, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Northwell Health

Queens, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of Oregon

Eugene, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Temple University

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

HEP and co-located Headspace Adelaide

Adelaide, South Australia, Australia

Headspace, Craigieburn

Craigieburn, Victoria, Australia

Headspace, Glenroy

Glenroy, Victoria, Australia

Headspace Melton

Melton South, Victoria, Australia

Orygen Specialist Programs, Melbourne

Parkville, Victoria, Australia

Headspace, Sunshine

Sunshine, Victoria, Australia

Headspace, Werribee

Werribee, Victoria, Australia

University of Calgary

Calgary, Alberta, Canada

McGill University

Montreal, Quebec, Canada

Hospital Clínico Universidad de Chile (HCUCH)

Santiago, Santiago Metropolitan, Chile

Shanghai Jiao Tong University

Shanghai, China

Copenhagen Research Center for Mental Health (CORE)

Copenhagen, Denmark

Klinik für Psychiatrie und Psychotherapie, University of Cologne

Cologne, Brescia, Germany

The University Hospital Jena, Department of Psychiatry

Jena, Thuringia, Germany

Ludwig-Maximilians-Universität Munich

Munich, Germany

The University of Hong Kong, Department of Psychiatry

Hong Kong, Hong Kong

University of Pavia

Pavia, Pavia, Italy

Early Psychosis Intervention Programme (EPIP) Clinic, Institute of Mental Health

Singapore, Singapore

Department of Psychiatry, Chonnam National University Hospital & Mindlink

Gwangju, South Korea

Seoul National University College of Medicine

Seoul, South Korea

Instituto de Psiquiatría y Salud Mental Hospital General Universitario Gregorio Marañón

Madrid, Spain

Treatment and Early Intervention in Psychosis Program (TIPP) & Center for Psychiatric Neuroscience (CNP), Department of Psychiatry, Lausanne University Hospital

Lausanne, Switzerland

Forward Thinking Birmingham

Birmingham, United Kingdom

University of Cambridge

Cambridge, United Kingdom

King's College London

London, United Kingdom