AMP SCZ® Observational Study: PREDICT-DPACC (AMP SCZ)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Psychosis; Remission; Conversion; Clinical High Risk

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).

• Study Type: Observational
• Enrollment (Estimated): 2617

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • HEP and co-located Headspace Adelaide
  • Victoria
    • Craigieburn, Victoria, Australia, 3064
      • Headspace, Craigieburn
    • Glenroy, Victoria, Australia, 3046
      • Headspace, Glenroy
    • Melton South, Victoria, Australia, 3338
      • Headspace Melton
    • Parkville, Victoria, Australia, 3122
      • Orygen Specialist Programs, Melbourne
    • Sunshine, Victoria, Australia, 3020
      • Headspace, Sunshine
    • Werribee, Victoria, Australia, 3030
      • Headspace, Werribee
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary
  • Quebec
    • Montreal, Quebec, Canada, H4H 1R3
      • McGill University
• Chile
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile, 8380456
      • Hospital Clínico Universidad de Chile (HCUCH)
• China
  • Shanghai, China, 200030
    • Shanghai Jiao Tong University
• Denmark
  • Copenhagen, Denmark, DK-2900
    • Copenhagen Research Center for Mental Health (CORE)
• Germany
  • Munich, Germany
    • Ludwig-Maximilians-Universität Munich
  • Brescia
    • Cologne, Brescia, Germany, 50931
      • Klinik für Psychiatrie und Psychotherapie, University of Cologne
  • Thuringia
    • Jena, Thuringia, Germany, 07743
      • The University Hospital Jena, Department of Psychiatry
• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong, Department of Psychiatry
• Italy
  • Pavia
    • Pavia, Pavia, Italy, 27100
      • University of Pavia
• Singapore
  • Singapore, Singapore, 539747
    • Early Psychosis Intervention Programme (EPIP) Clinic, Institute of Mental Health
• South Korea
  • Gwangju, South Korea, 61469
    • Department of Psychiatry, Chonnam National University Hospital & Mindlink
  • Seoul, South Korea, 03082
    • Seoul National University College of Medicine
• Spain
  • Madrid, Spain
    • Instituto de Psiquiatría y Salud Mental Hospital General Universitario Gregorio Marañón
• Switzerland
  • Lausanne, Switzerland, 1008
    • Treatment and Early Intervention in Psychosis Program (TIPP) & Center for Psychiatric Neuroscience (CNP), Department of Psychiatry, Lausanne University Hospital
• United Kingdom
  • Birmingham, United Kingdom, B4 6DF
    • Forward Thinking Birmingham
  • Cambridge, United Kingdom, CB4 1PR
    • University of Cambridge
  • London, United Kingdom, SE5 8AF
    • King's College London
• United States
  • California
    • Irvine, California, United States, 92697
      • University of California Irvine
    • Los Angeles, California, United States, 90095,
      • University of California Los Angeles
    • San Diego, California, United States, 92103
      • University of California San Diego
    • San Francisco, California, United States, 94121
      • University of California San Francisco
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Healthcare
    • New Haven, Connecticut, United States, 06519
      • Yale University/Connecticut Mental Health Center
  • Georgia
    • Athens, Georgia, United States, 30602
      • University of Georgia
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • Queens, New York, United States, 11004
      • Northwell Health
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
  • Oregon
    • Eugene, Oregon, United States, 97401
      • University of Oregon
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19122
      • Temple University
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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/).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion to Psychosis	Conversion to psychosis as defined by psychosis threshold criteria on the PSYCHS.	By 24 month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission	Recovery from CHR as defined by PSYCHS criteria.	By 24 month follow-up.
Non-conversion/Non-remission	Continued CHR condition as defined by PSYCHS criteria.	By 24 month follow-up.

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute of Mental Health (NIMH); Yale University; Orygen
• Investigators: Principal Investigator: Scott Woods, M.D., Yale University; Principal Investigator: Martha E Shenton, Ph.D., Brigham and Women's Hospital/Harvard Medical School; Principal Investigator: Barnaby Nelson, Ph.D., Center for Youth Mental Health at the University of Melbourne/Orygen

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: biomarkers; phenotype
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Psychotic Disorders
• Other Study ID Numbers: 2020P002267; U24MH124629 (U.S. NIH Grant/Contract); U01MH124631 (U.S. NIH Grant/Contract); U01MH124639 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

AMP SCZ will be collecting a wide range of data types as described below:

• Ascertainment & outcome measures - will be stored as tabular data (multiple formats possible, csv)
• Neurocognitive measures - will be stored as tabular data (multiple formats possible, csv)
• EEG data
• MRI data
• Audio/Video data

• Digital Biomarkers (EMA) including

  • Phone Surveys
  • Phone GPS
  • Phone Accelerometry
  • Phone Audio diary
  • Watch/sensor actigraphy (captured by an Axivity device)
• Genetics & Fluid Biomarkers metadata forms

Data will include QCed raw data as well as processed data and derivatives. Sensitive data will be identified and separated from non-sensitive data.

Data sharing will be consistent with subject consent data use limitations.

• IPD Sharing 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.
• IPD Sharing Access Criteria: For accessing data on the NDA please see https://nda.nih.gov/ampscz/access-data-info.html
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Study Data/Documents

1. Individual Participant Data Set

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No