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Clinical Trials in Canada / NCT05905003
Active, not recruiting Observational

AMP SCZ® Observational Study: PREDICT-DPACC

NCT05905003 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2022-06-02
Last updated
2025-10-31

Condition(s) studied

Clinical High RiskPsychosisRemissionConversion

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
30 Years
Healthy volunteers
Accepted
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/).

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
University of California Irvine Irvine California
University of California Los Angeles Los Angeles California
University of California San Diego San Diego California
University of California San Francisco San Francisco California
Hartford Healthcare Hartford Connecticut
Yale University/Connecticut Mental Health Center New Haven Connecticut
University of Georgia Athens Georgia
Northwestern University Evanston Illinois
Beth Israel Deaconess Medical Center Boston Massachusetts
Washington University St Louis Missouri
Icahn School of Medicine at Mount Sinai New York New York
Northwell Health Queens New York
University of North Carolina at Chapel Hill Chapel Hill North Carolina
University of Oregon Eugene Oregon
University of Pennsylvania Philadelphia Pennsylvania
Temple University Philadelphia Pennsylvania
University of Pittsburgh Pittsburgh Pennsylvania
HEP and co-located Headspace Adelaide Adelaide South Australia
Headspace, Craigieburn Craigieburn Victoria
Headspace, Glenroy Glenroy Victoria
Headspace Melton Melton South Victoria
Orygen Specialist Programs, Melbourne Parkville Victoria
Headspace, Sunshine Sunshine Victoria
Headspace, Werribee Werribee Victoria
University of Calgary Calgary Alberta
McGill University Montreal Quebec
Hospital Clínico Universidad de Chile (HCUCH) Santiago Santiago Metropolitan
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
The University Hospital Jena, Department of Psychiatry Jena Thuringia
Ludwig-Maximilians-Universität Munich Munich Germany
The University of Hong Kong, Department of Psychiatry Hong Kong Hong Kong
University of Pavia Pavia Pavia
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

+ 2 more sites — see the full list on the official registry below.

More Brigham and Women's Hospital trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05905003 on ClinicalTrials.gov ↗ ← All trials in Canada