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Observational study to predict outcomes in individuals at high risk for psychosis

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

Observational Brigham and Women's Hospital · NCT05905003

This study is trying to see if certain tests and biological markers can help predict how young people at high risk for psychosis will do in the future.

Quick facts

Study typeObservational
Enrollment2617 (estimated)
Ages12 Years to 30 Years
SexAll
SponsorBrigham and Women's Hospital Academic / other
Locations42 sites (Irvine, California and 41 other locations)
Trial IDNCT05905003 on ClinicalTrials.gov

What this trial studies

The AMP SCZ Observational Study: PREDICT-DPACC aims to develop algorithms that utilize clinical assessments and biomarkers to predict the outcomes of individuals aged 12 to 30 who are at clinical high risk for psychosis. This international collaboration involves multiple institutions and focuses on identifying which participants are likely to experience remission, acute psychotic episodes, or persistent symptoms. By analyzing a combination of clinical and biological data, the study seeks to enhance early intervention strategies for schizophrenia. The findings could lead to improved treatment efficacy assessments for at-risk individuals.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 12 to 30 who meet the diagnostic criteria for clinical high risk for psychosis.

Not a fit: Patients with a history of significant antipsychotic medication exposure or those who have experienced a clinically relevant psychotic episode may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide early indicators for effective treatments in individuals at high risk for developing psychosis.

How similar studies have performed: Other studies have shown promise in using similar biomarker-informed approaches to predict psychosis outcomes, indicating a potential for success in this novel initiative.

Eligibility criteria

Show full inclusion / exclusion criteria 
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/).

Where this trial is running

Irvine, California and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Clinical High RiskPsychosisRemissionConversionbiomarkersphenotype
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.