AMP SCZ® Observational Study: PREDICT-DPACC

NCT ID: NCT05905003

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2617 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-02
• Study Completion Date: 2027-04-30

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.

Detailed Description

The Accelerating Medicines Partnership (AMP®) is a public-private partnership between the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and multiple public and private organizations. The goal of the AMP Schizophrenia (AMP SCZ) program, a multi-continent consortium, is to develop a deep biomarker-informed functional characterization and longitudinal clinical profiling of study participants at clinical high risk (CHR) for psychosis. The data will support the development of algorithms of clinical and biological measures to predict the trajectories and outcomes of CHR individuals to identify enriched CHR patient populations to enable proof of principle intervention studies for early intervention in schizophrenia. These tools will allow the assessment of biomarkers and outcome measures as early indicators of pharmacologic treatment efficacy. See the AMP SCZ website link for a detailed description of study goals (https://www.ampscz.org/about/goals/).

The Accelerating Medicines Partnership® Schizophrenia Observational Study: Psychosis Risk Evaluation, Data Integration, and Computational Technologies Data Processing, Analysis and Coordination Center (AMP SCZ® Observational Study: PREDICT-DPACC) based out of Brigham and Women's Hospital (BWH) and Mass General Brigham (MGB) is one of three research projects supported by the AMP SCZ program.

The AMP SCZ Observational Study: PREDICT-DPACC works with two Clinical High Risk (CHR) research networks (described below) to meet the following goals:

• Capture data from the research networks in a uniform manner.
• Build flexible infrastructure to accommodate multiple data types.
• Develop and refine pipelines that provide rapid data processing (in close to real-time) and quality assurance (QA) and quality control (QC).
• Provide data coordination, management, and monitoring of data.
• Develop powerful and robust stratification tools to identify & validate biomarkers and predict individual outcome trajectories.
• Assist in archiving data and making it publicly available in the NIMH Data Archive (NDA). Please see (https://nda.nih.gov/ampscz/).
• Disseminate information, including tools developed, to the general research community, and provide outreach to the community via a website.

MGB institutions do not provide or enroll participants for this study but serve as the AMP SCZ DPACC for two CHR Research Networks (RNs) where consent and all clinical testing and data collection occur. MGB is a data recipient only, not a data provider. The Mass General Brigham IRB is the IRB of record for the AMP SCZ® Observational Study: PREDICT-DPACC and the IRB status is exempt.

The two CHR research networks (RNs) that also make up the AMP SCZ program are:

The Psychosis-Risk Outcomes Network (ProNET) is based out of Yale University, which serves as the hub for this network and consists of a network of sites in the US, Canada, Europe, and Asia. Northwell Health is the IRB of record for all US sites in the ProNET RN. All foreign ProNET sites submit to their local IRBs.

The Trajectories and Predictors in the Clinical High Risk for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT), is based out of the Center for Youth Mental Health at the University of Melbourne and at Orygen, Melbourne, Australia, which serves as the hub for this network, and consists of a network of sites in Australia, Europe, and Asia. The Melbourne Health Research Governance and Ethics Office for Research is the IRB of record for all Australian sites in the PRESCIENT research network. European and Asian sites submit to their local IRBs.

Acquisition Sites collect the data and transfer it directly to Brigham and Women's Hospital, which is the main site for the Data Processing Analysis and Coordination Center (DPACC).

See the AMP SCZ website for a searchable map with contact information for all study sites (https://www.ampscz.org/about/map/). Please also see the AMP SCZ website for additional information about the ProNET and PRESCIENT research networks and the PREDICT-DPACC coordination center (https://www.ampscz.org/about/networks-coordination/).

This is a non-interventional study examining clinical trajectories and predictors of outcomes in the CHR population. The CHR cohort and HCs will be assessed with a core set of measures at baseline and 2 months post-baseline, with additional assessments completed at other time points. CHR subjects will be assessed longitudinally for 2 years. Participants who develop first-episode psychosis ('converted' cases) during their study participation will continue to be assessed as scheduled. Measures include clinical, cognitive, neurophysiology, neuroimaging, genetics and fluid biomarkers, speech and facial expression (audio/video recordings are optional), and outcome assessments. Digital assessments such as daily ecological momentary assessment (daily digital diary entries) and passive sensing measurements (actigraphy and geolocation) are optional. See the AMP SCZ website for detailed descriptions of the study design (https://www.ampscz.org/scientists/design/) and protocol (https://www.ampscz.org/wp-content/uploads/2023/01/AMP-SCZ-Protocol-Summary-for-Distribution_24JAN2023.pdf).

Conditions

Clinical High Risk; Psychosis; Remission; Conversion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

HC

Healthy Control (HC) Subjects

No interventions assigned to this group

Eligibility Criteria

Inclusion 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).

Exclusion Criteria

• 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/).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Orygen

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Martha E Shenton

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martha E Shenton, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital/Harvard Medical School

Scott Woods, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Barnaby Nelson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Countries

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

Provided Documents

Document Type: Study Protocol: ProNET Study Protocol

View Document

Document Type: Study Protocol: PRESCIENT Study Protocol

View Document

Document Type: Informed Consent Form: ProNET CHR ICF

View Document

Document Type: Informed Consent Form: PRESCIENT CHR Self

View Document

Study Documents

Document Type: Individual Participant Data Set

View Document

Related Links

http://ampscz.org

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.

Other Identifiers

U24MH124629

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01MH124631

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01MH124639

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020P002267

Identifier Type: -

Identifier Source: org_study_id