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Clinical High RiskAMP SCZNCT05905003

AMP SCZ® Observational Study: PREDICT-DPACC

An observational study of Clinical High Risk and Psychosis, run by Brigham and Women's Hospital at 42 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Clinical High Risk, Psychosis, Remission
How many people
2,617 participants
Where
42 sitesin 14 countries
Study dates
2 Jun 2022to 30 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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/).

Trial locations and contacts

42 sites in 14 countries.

42 sites in 14 countries

United States17 sites

  • University of Georgia

    Athens, Georgia, 30602

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • University of Oregon

    Eugene, Oregon, 97401

  • Northwestern University

    Evanston, Illinois, 60201

  • Hartford Healthcare

    Hartford, Connecticut, 06106

  • University of California Irvine

    Irvine, California, 92697

  • University of California Los Angeles

    Los Angeles, California, 90095,

  • Yale University/Connecticut Mental Health Center

    New Haven, Connecticut, 06519

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University

    Philadelphia, Pennsylvania, 19122

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Northwell Health

    Queens, New York, 11004

  • University of California San Diego

    San Diego, California, 92103

  • University of California San Francisco

    San Francisco, California, 94121

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

Australia7 sites

  • HEP and co-located Headspace Adelaide

    Adelaide, South Australia, 5000

  • Headspace, Craigieburn

    Craigieburn, Victoria, 3064

  • Headspace, Glenroy

    Glenroy, Victoria, 3046

  • Headspace Melton

    Melton South, Victoria, 3338

  • Orygen Specialist Programs, Melbourne

    Parkville, Victoria, 3122

  • Headspace, Sunshine

    Sunshine, Victoria, 3020

  • Headspace, Werribee

    Werribee, Victoria, 3030

Other trials in Australia

Germany3 sites

  • Klinik für Psychiatrie und Psychotherapie, University of Cologne

    Cologne, Brescia, 50931

  • The University Hospital Jena, Department of Psychiatry

    Jena, Thuringia, 07743

  • Ludwig-Maximilians-Universität Munich

    Munich

Other trials in Germany

United Kingdom3 sites

  • Forward Thinking Birmingham

    Birmingham, B4 6DF

  • University of Cambridge

    Cambridge, CB4 1PR

  • King's College London

    London, SE5 8AF

Other trials in United Kingdom

Canada2 sites

  • University of Calgary

    Calgary, Alberta

  • McGill University

    Montreal, Quebec, H4H 1R3

Other trials in Canada

South Korea2 sites

  • Department of Psychiatry, Chonnam National University Hospital & Mindlink

    Gwangju, 61469

  • Seoul National University College of Medicine

    Seoul, 03082

Other trials in South Korea

Chile1 site

  • Hospital Clínico Universidad de Chile (HCUCH)

    Santiago, Santiago Metropolitan, 8380456

Other trials in Chile

China1 site

  • Shanghai Jiao Tong University

    Shanghai, 200030

Other trials in China

Denmark1 site

  • Copenhagen Research Center for Mental Health (CORE)

    Copenhagen, DK-2900

Other trials in Denmark

Hong Kong1 site

  • The University of Hong Kong, Department of Psychiatry

    Hong Kong

Other trials in Hong Kong

Italy1 site

  • University of Pavia

    Pavia, Pavia, 27100

Other trials in Italy

Singapore1 site

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

    Singapore, 539747

Other trials in Singapore

Spain1 site

  • Instituto de Psiquiatría y Salud Mental Hospital General Universitario Gregorio Marañón

    Madrid

Other trials in Spain

Switzerland1 site

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

    Lausanne, 1008

Other trials in Switzerland

About this study

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

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.

Read the 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).

Keywords
biomarkers, phenotype
Medical subject headings
Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05905003
Study groupRoleWhat they receive
CHRClinical 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).
HCHealthy Control (HC) Subjects

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Conversion to Psychosis

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

    Measured: By 24 month follow-up.

Secondary outcomes (2)

  1. Remission

    Recovery from CHR as defined by PSYCHS criteria.

    Measured: By 24 month follow-up.

  2. Non-conversion/Non-remission

    Continued CHR condition as defined by PSYCHS criteria.

    Measured: By 24 month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start2 Jun 2022
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,617 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05905003
Sponsor's protocol ID
2020P002267
Other IDs
U24MH124629, U01MH124631, U01MH124639
Acronym
AMP SCZ
Status last verified
Oct 2025
First submitted
17 May 2023
Last updated
31 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Stefanelli R, Oliver D, Damiani S, Orlandi M, Provenzani U, Bortolin E, Rovida M, Addington J, Alameda L, Arango C, Breitborde NJ, Broome M, Cadenhead KS, Calkins ME, Carrion RE, Castillo-Passi RI, Chen YHE, Choi J, Conus P, Cornblatt BA, Diaz-Caneja CM, Ellman LM, Gaspar PA, Gerber C, Birkedal Glenthoj L, Horton LE, Hui CL, Kambeitz J, Kambeitz-Ilankovic L, Keshavan MS, Kim M, Kim SW, Koutsouleris N, Kwon JS, Langbein K, Mamah D, Mathalon DH, Mittal VA, Nordentoft M, Pearlson GD, Penzel N, Perez J, Perkins DO, Powers AR 3rd, Rogers JR, Sabb FW, Schiffman J, Shah J, Silverstein SM, Smesny S, Stone WS, Strauss GP, Thompson JL, Upthegrove R, Verma S, Wang J, Wolf DH, Zhang T, Bouix S, Corcoran CM, Kapur T, Pasternak O, Bearden C, Kahn RS, Kane JM, McGorry PD, Nelson B, Shenton ME, Woods SW; Accelerating Medicines Partnership Schizophrenia (AMP SCZ); Fusar-Poli P. External validation and refinement of the Psychosis Polyrisk Score to detect individuals at clinical high risk for psychosis. BMJ Ment Health. 2026 Sep 28;29(1):e302838. doi: 10.1136/bmjment-2026-302838.

    PubMed 42805768

  • Damiani S, Orlandi M, Provenzani U, Bortolin E, Rovida M, Stefanelli R, Addington J, Alameda L, Arango C, Breitborde NJK, Broome MR, Cadenhead KS, Calkins ME, Carrion RE, Castillo-Passi RI, Chen EYH, Choi J, Conus P, Cornblatt BA, Diaz-Caneja CM, Ellman LM, Fogarty A, Gaspar PA, Gerber C, Glenthoj LB, Horton LE, Hui CLM, Kambeitz J, Kambeitz-Ilankovic L, Keshavan MS, Kim M, Kim SW, Koutsouleris N, Kristof Z, Kwon JS, Langbein K, Mamah D, Mathalon DH, Mittal VA, Nguyen J, Nordentoft M, Pearlson GD, Penzel N, Perez J, Perkins DO, Powers AR 3rd, Rogers J, Sabb FW, Schiffman J, Shah JL, Silverstein SM, Smesny S, Stone WS, Strauss GP, Thompson JL, Upthegrove R, Verma S, Wannan C, Wang J, Wastler H, Wolf DH, Zhang T, Bouix S, Corcoran CM, Kapur T, Pasternak O, Bearden CE, Kahn RS, Kane JM, McGorry PD, Nelson B, Shenton ME, Woods SW, Fusar-Poli P. Unraveling Suicidal Ideation and Behaviors in a Global Cohort of Individuals at Clinical High-Risk for Psychosis: Multivariable Correlates and Subthreshold Psychotic Symptoms. Acta Psychiatr Scand. 2026 Sep 11. doi: 10.1111/acps.70138. Online ahead of print.

    PubMed 42728096

Questions about this trial

What is this clinical trial studying?

An observational study of Clinical High Risk and Psychosis, run by Brigham and Women's Hospital at 42 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Australia, Germany, United Kingdom, Canada and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conversion to Psychosis (time frame: By 24 month follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05905003, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.

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