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
- Diseases
- Schizophrenia
- 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
Sites (42)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HEP and co-located Headspace Adelaide Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Headspace, Craigieburn Coordinator of this site? Confirm its status | Craigieburn | Australia | Unknown status |
| Headspace, Glenroy Coordinator of this site? Confirm its status | Glenroy | Australia | Unknown status |
| Headspace Melton Coordinator of this site? Confirm its status | Melton South | Australia | Unknown status |
| Orygen Specialist Programs, Melbourne Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Headspace, Sunshine Coordinator of this site? Confirm its status | Sunshine | Australia | Unknown status |
| Headspace, Werribee Coordinator of this site? Confirm its status | Werribee | Australia | Unknown status |
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| McGill University Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Treatment and Early Intervention in Psychosis Program (TIPP) & Center for Psychiatric Neuroscience (CNP), Department of Psychiatry, Lausanne University Hospital Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Hospital Clínico Universidad de Chile (HCUCH) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Klinik für Psychiatrie und Psychotherapie, University of Cologne Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| The University Hospital Jena, Department of Psychiatry Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
| Ludwig-Maximilians-Universität Munich Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Copenhagen Research Center for Mental Health (CORE) Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Instituto de Psiquiatría y Salud Mental Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Forward Thinking Birmingham Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| University of Cambridge Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| King's College London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The University of Hong Kong, Department of Psychiatry Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| University of Pavia Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Department of Psychiatry, Chonnam National University Hospital & Mindlink Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| Seoul National University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Early Psychosis Intervention Programme (EPIP) Clinic, Institute of Mental Health Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| University of Georgia Coordinator of this site? Confirm its status | Athens | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| University of Oregon Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
| Hartford Healthcare Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| University of California, Irvine Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Yale University/Connecticut Mental Health Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Temple University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | Queens | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.