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Can we predict psychosis? global study seeks answers

NCT ID NCT05905003

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study is collecting data from 2,617 young people (ages 12-30) at clinical high risk for psychosis, plus healthy controls, across 13 countries. Researchers will use clinical assessments, cognitive tests, and biomarkers to build algorithms that predict who will recover, who will develop psychosis, and who will have ongoing symptoms. The goal is to improve early detection and pave the way for future treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better prediction tools to identify which young people at high risk for psychosis will recover, worsen, or develop schizophrenia, enabling earlier and more targeted interventions.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test any therapy. The algorithms developed may not be accurate enough for widespread clinical use without further validation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,617 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

12 to 30 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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/).

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Conditions

The condition(s) this trial relates to.

conversion disorder psychotic disorder Psychotic Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clinical high risk Conversion Psychosis Remission

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115, United States

  • Copenhagen Research Center for Mental Health (CORE)

    Copenhagen, DK-2900, Denmark

  • Department of Psychiatry, Chonnam National University Hospital & Mindlink

    Gwangju, 61469, South Korea

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

    Singapore, 539747, Singapore

  • Forward Thinking Birmingham

    Birmingham, B4 6DF, United Kingdom

  • HEP and co-located Headspace Adelaide

    Adelaide, South Australia, 5000, Australia

  • Hartford Healthcare

    Hartford, Connecticut, 06106, United States

  • Headspace Melton

    Melton South, Victoria, 3338, Australia

  • Headspace, Craigieburn

    Craigieburn, Victoria, 3064, Australia

  • Headspace, Glenroy

    Glenroy, Victoria, 3046, Australia

  • Headspace, Sunshine

    Sunshine, Victoria, 3020, Australia

  • Headspace, Werribee

    Werribee, Victoria, 3030, Australia

  • Hospital Clínico Universidad de Chile (HCUCH)

    Santiago, Santiago Metropolitan, 8380456, Chile

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

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

    Madrid, Spain

  • King's College London

    London, SE5 8AF, United Kingdom

  • Klinik für Psychiatrie und Psychotherapie, University of Cologne

    Cologne, Brescia, 50931, Germany

  • Ludwig-Maximilians-Universität Munich

    Munich, Germany

  • McGill University

    Montreal, Quebec, H4H 1R3, Canada

  • Northwell Health

    Queens, New York, 11004, United States

  • Northwestern University

    Evanston, Illinois, 60201, United States

  • Orygen Specialist Programs, Melbourne

    Parkville, Victoria, 3122, Australia

  • Seoul National University College of Medicine

    Seoul, 03082, South Korea

  • Shanghai Jiao Tong University

    Shanghai, 200030, China

  • Temple University

    Philadelphia, Pennsylvania, 19122, United States

  • The University Hospital Jena, Department of Psychiatry

    Jena, Thuringia, 07743, Germany

  • The University of Hong Kong, Department of Psychiatry

    Hong Kong, Hong Kong

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

    Lausanne, 1008, Switzerland

  • University of Calgary

    Calgary, Alberta, Canada

  • University of California Irvine

    Irvine, California, 92697, United States

  • University of California Los Angeles

    Los Angeles, California, 90095,, United States

  • University of California San Diego

    San Diego, California, 92103, United States

  • University of California San Francisco

    San Francisco, California, 94121, United States

  • University of Cambridge

    Cambridge, CB4 1PR, United Kingdom

  • University of Georgia

    Athens, Georgia, 30602, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Oregon

    Eugene, Oregon, 97401, United States

  • University of Pavia

    Pavia, Pavia, 27100, Italy

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Yale University/Connecticut Mental Health Center

    New Haven, Connecticut, 06519, United States

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