AMP SCZ® Observational Study: PREDICT-DPACC

ID#: NCT05905003

Age: 12 - 30 years

Gender: All

Healthy Subjects: Accepts Healthy Volunteers

Recruitment Status: Recruiting

Start Date: June 02, 2022

End Date: May 31, 2025

Contact Information:
Martha E Shenton, Ph.D.
617-699-6152
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:

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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