NCT05905003: AMP SCZ

AMP SCZ® Observational Study: PREDICT-DPACC

Active, enrolled Last updated 31 October 2025

What this trial tests

trial in Clinical High Risk in 2,617 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

2 June 2022

Primary endpoint
30 April 2027

30 April 2027

Quick facts

Lead sponsor	Brigham and Women's Hospital
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	2,617
Start date	2 June 2022
Primary completion	30 April 2027
Estimated completion	30 April 2027
Sites	42 locations across Denmark, Hong Kong, Italy, Chile, United Kingdom, Germany, South Korea, Canada

Conditions studied

• Clinical High Risk — all drugs for Clinical High Risk →
• Psychosis — all drugs for Psychosis →
• Remission — all drugs for Remission →
• Conversion — all drugs for Conversion →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 12 to 30, any sex, with Clinical High Risk or Psychosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cognitive assessment in the Accelerating Medicines Partnership® Schizophrenia Program: harmonization priorities and strategies in a diverse international sample.
   Allott K, Yassin W, Alameda L, Billah T, et al · · 2025 · cited 7× · PMID 40128256 · DOI 10.1038/s41537-025-00578-1
2. The MR neuroimaging protocol for the Accelerating Medicines Partnership® Schizophrenia Program.
   Harms MP, Cho KK, Anticevic A, Bolo NR, et al · · 2025 · cited 6× · PMID 40175382 · DOI 10.1038/s41537-025-00581-6
3. The electroencephalography protocol for the Accelerating Medicines Partnership® Schizophrenia Program: Reliability and stability of measures.
   Mathalon DH, Nicholas S, Roach BJ, Billah T, et al · · 2025 · cited 5× · PMID 40480970 · DOI 10.1038/s41537-025-00622-0
4. Enabling FAIR data stewardship in complex international multi-site studies: Data Operations for the Accelerating Medicines Partnership® Schizophrenia Program.
   Billah T, Cho KIK, Borders O, Chung Y, et al · · 2025 · cited 5× · PMID 40180978 · DOI 10.1038/s41537-025-00560-x
5. Collecting language, speech acoustics, and facial expression to predict psychosis and other clinical outcomes: strategies from the AMP® SCZ initiative.
   Bilgrami ZR, Castro E, Agurto C, Liebenthal E, et al · · 2025 · cited 1× · PMID 41093845 · DOI 10.1038/s41537-025-00669-z