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NCT05905003Active, not recruiting

AMP SCZ® Observational Study: PREDICT-DPACC

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

Source: ClinicalTrials.gov · Last updated 31 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
2617 (estimated)
First submitted
17 May 2023
Start date
2 Jun 2022
Primary completion date
30 Apr 2027
Lead sponsor
Brigham and Women's Hospital
NCT number
NCT05905003

What you commit to

  • Study type: Observational
  • Planned participants: 2617
  • From 2 Jun 2022 to the primary completion date, 30 Apr 2027
  • 42 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Antipsychotic medication exposure equivalent to a total lifetime haloperidol dose of \>50 mg or current antipsychotic medication at time of screening assessment;

Other illness

  • Documented history of intellectual disability;
  • Past or current clinically relevant central nervous system disorder;

Other

  • 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/).

Who the study is looking for

  • 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).

Age in the registry: 12 years to 30 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (42)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
HEP and co-located Headspace Adelaide
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AdelaideAustraliaUnknown status
Headspace, Craigieburn
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CraigieburnAustraliaUnknown status
Headspace, Glenroy
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GlenroyAustraliaUnknown status
Headspace Melton
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Melton SouthAustraliaUnknown status
Orygen Specialist Programs, Melbourne
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ParkvilleAustraliaUnknown status
Headspace, Sunshine
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SunshineAustraliaUnknown status
Headspace, Werribee
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WerribeeAustraliaUnknown status
University Of Calgary
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CalgaryCanadaUnknown status
McGill University
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MontrealCanadaUnknown status
Treatment and Early Intervention in Psychosis Program (TIPP) & Center for Psychiatric Neuroscience (CNP), Department of Psychiatry, Lausanne University Hospital
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LausanneSwitzerlandUnknown status
Hospital Clínico Universidad de Chile (HCUCH)
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SantiagoChileUnknown status
Shanghai Jiao Tong University
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ShanghaiChinaUnknown status
Klinik für Psychiatrie und Psychotherapie, University of Cologne
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CologneGermanyUnknown status
The University Hospital Jena, Department of Psychiatry
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JenaGermanyUnknown status
Ludwig-Maximilians-Universität Munich
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MunichGermanyUnknown status
Copenhagen Research Center for Mental Health (CORE)
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CopenhagenDenmarkUnknown status
Instituto de Psiquiatría y Salud Mental Hospital General Universitario Gregorio Marañón
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MadridSpainUnknown status
Forward Thinking Birmingham
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BirminghamUnited KingdomUnknown status
University of Cambridge
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CambridgeUnited KingdomUnknown status
King's College London
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LondonUnited KingdomUnknown status
The University of Hong Kong, Department of Psychiatry
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Hong KongHong Kong SAR ChinaUnknown status
University of Pavia
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PaviaItalyUnknown status
Department of Psychiatry, Chonnam National University Hospital & Mindlink
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GwangjuSouth KoreaUnknown status
Seoul National University College of Medicine
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SeoulSouth KoreaUnknown status
Early Psychosis Intervention Programme (EPIP) Clinic, Institute of Mental Health
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SingaporeSingaporeUnknown status
University of Georgia
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AthensUnited StatesUnknown status
Beth Israel Deaconess Medical Center
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BostonUnited StatesUnknown status
University of North Carolina at Chapel Hill
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Chapel HillUnited StatesUnknown status
University of Oregon
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EugeneUnited StatesUnknown status
Northwestern University
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EvanstonUnited StatesUnknown status
Hartford Healthcare
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HartfordUnited StatesUnknown status
University of California, Irvine
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IrvineUnited StatesUnknown status
University of California, Los Angeles
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Los AngelesUnited StatesUnknown status
Yale University/Connecticut Mental Health Center
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New HavenUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Temple University
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PhiladelphiaUnited StatesUnknown status
University of Pittsburgh
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PittsburghUnited StatesUnknown status
Northwell Health
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QueensUnited StatesUnknown status
University of California San Diego
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San DiegoUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.