AMP SCZ® Observational Study: PREDICT-DPACC

NCT05905003 | Active Not Recruiting

• 4 other identifiers: 2020P002267U24MH124629U01MH124631U01MH124639
• Study Type: observational
• Target: 2,617
• Locations: 14 countries
• Sites: 42

Brief 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

Keywords

biomarkers; phenotype

Outcome Measures

Primary Outcomes (1)

• Conversion to Psychosis

  Conversion to psychosis as defined by psychosis threshold criteria on the PSYCHS.

  By 24 month follow-up.

Secondary Outcomes (2)

• Remission

  By 24 month follow-up.

• Non-conversion/Non-remission

  By 24 month follow-up.

Study Arms (2)

CHR

Clinical High Risk (CHR) for psychosis subjects meeting diagnostic criteria for CHR on the Positive SYmptoms and Diagnostic Criteria for the CAARMS Harmonized with the SIPS (PSYCHS).

HC

Healthy Control (HC) Subjects

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects are recruited and tested at 42 Clinical High Risk research/clinical treatment sites throughout the US, Canada, Australia, Europe, South America, and Asia. The individual sites are part of 2 Research Networks, the Psychosis-Risk Outcomes Network (ProNET) based out of Yale University, and the Trajectories and Predictors in the CHR for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT) based out of the University of Melbourne/Orygen.

You may qualify if:

• 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).

You may not qualify if:

• 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.
• See also the AMP SCZ website link for a description of eligibility criteria (https://www.ampscz.org/participate/eligible/).

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Orygen: collaborator
• Yale University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (42)

University of California Irvine

Irvine, California, 92697, United States

Location

University of California Los Angeles

Los Angeles, California, 90095,, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

University of California San Francisco

San Francisco, California, 94121, United States

Location

Hartford Healthcare

Hartford, Connecticut, 06106, United States

Location

Yale University/Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

University of Georgia

Athens, Georgia, 30602, United States

Location

Northwestern University

Evanston, Illinois, 60201, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Northwell Health

Queens, New York, 11004, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University of Oregon

Eugene, Oregon, 97401, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

HEP and co-located Headspace Adelaide

Adelaide, South Australia, 5000, Australia

Location

Headspace, Craigieburn

Craigieburn, Victoria, 3064, Australia

Location

Headspace, Glenroy

Glenroy, Victoria, 3046, Australia

Location

Headspace Melton

Melton South, Victoria, 3338, Australia

Location

Orygen Specialist Programs, Melbourne

Parkville, Victoria, 3122, Australia

Location

Headspace, Sunshine

Sunshine, Victoria, 3020, Australia

Location

Headspace, Werribee

Werribee, Victoria, 3030, Australia

Location

University of Calgary

Calgary, Alberta, Canada

Location

McGill University

Montreal, Quebec, H4H 1R3, Canada

Location

Hospital Clínico Universidad de Chile (HCUCH)

Santiago, Santiago Metropolitan, 8380456, Chile

Location

Shanghai Jiao Tong University

Shanghai, 200030, China

Location

Copenhagen Research Center for Mental Health (CORE)

Copenhagen, DK-2900, Denmark

Location

Klinik für Psychiatrie und Psychotherapie, University of Cologne

Cologne, Brescia, 50931, Germany

Location

The University Hospital Jena, Department of Psychiatry

Jena, Thuringia, 07743, Germany

Location

Ludwig-Maximilians-Universität Munich

Munich, Germany

Location

The University of Hong Kong, Department of Psychiatry

Hong Kong, Hong Kong

Location

University of Pavia

Pavia, Pavia, 27100, Italy

Location

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

Singapore, 539747, Singapore

Location

Department of Psychiatry, Chonnam National University Hospital & Mindlink

Gwangju, 61469, South Korea

Location

Seoul National University College of Medicine

Seoul, 03082, South Korea

Location

Instituto de Psiquiatría y Salud Mental Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

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

Lausanne, 1008, Switzerland

Location

Forward Thinking Birmingham

Birmingham, B4 6DF, United Kingdom

Location

University of Cambridge

Cambridge, CB4 1PR, United Kingdom

Location

King's College London

London, SE5 8AF, United Kingdom

Location

Related Links

• The website conveys an overview of the aims and activities of the program for consumption by researchers, potential help seeking patients and their families as well as clinicians and clinics looking to update best practice guidelines.

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, leukocytes, plasma, saliva

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Martha E Shenton, Ph.D.

  Brigham and Women's Hospital/Harvard Medical School

  PRINCIPAL INVESTIGATOR

• Scott Woods, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• Barnaby Nelson, Ph.D.

  Center for Youth Mental Health at the University of Melbourne/Orygen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 15, 2023
• Study Start: June 2, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: NIMH Data Archive (NDA) Curated Release Environment. Curated releases will be made available to the larger research community approximately every 6 months. The Psychosis Risk Evaluation, Data Integration, and Computational Technologies (PREDICT) Data Processing, Analysis and Coordination Center (PREDICT-DPACC) will be responsible for packaging the data from the project that will be shared in curated releases and submitted to the NDA. This will follow standard NDA procedures with all NDA dictionaries and NDA QA/QC protocols. Data will include QCed raw data as well as processed data and derivatives. Sensitive data will be identified and separated from non-sensitive data. Qualified researchers will need to submit a Data Access Request to the NDA to see these data. The PREDICT-DPACC will not be responsible for granting access to these data on the NDA. NDA may decide to require separate agreements for sensitive vs non-sensitive data.
• Access Criteria: For accessing data on the NDA please see https://nda.nih.gov/ampscz/access-data-info.html

Locations

SG (1); GB (3); AU (7); CA (2); IT (1); CN (1); DK (1); DE (3); ES (1); HK (1); CL (1); CH (1); US (17); KR (2)