ACTIVE_NOT_RECRUITING

AMP SCZ® Observational Study: PREDICT-DPACC

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-06-02
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05905003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals between 12 and 30 years old;
  2. * Understand and sign an informed consent (or assent for minors) document;
  3. * Meet diagnostic criteria for CHR from the Positive SYmptoms and Diagnostic Criteria for the CAARMS Harmonized with the SIPS (PSYCHS).
  1. * Antipsychotic medication exposure equivalent to a total lifetime haloperidol dose of \>50 mg or current antipsychotic medication at time of screening assessment;
  2. * Documented history of intellectual disability;
  3. * Past or current clinically relevant central nervous system disorder;
  4. * Traumatic brain injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument;
  5. * Current or past treated or untreated psychotic episode, as determined using the PSYCHS.

Contacts and Locations

Principal Investigator

Martha E Shenton, Ph.D.
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital/Harvard Medical School
Scott Woods, M.D.
PRINCIPAL_INVESTIGATOR
Yale University
Barnaby Nelson, Ph.D.
PRINCIPAL_INVESTIGATOR
Center for Youth Mental Health at the University of Melbourne/Orygen

Study Locations (Sites)

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
Hartford Healthcare
Hartford, Connecticut, 06106
United States
Yale University/Connecticut Mental Health Center
New Haven, Connecticut, 06519
United States
University of Georgia
Athens, Georgia, 30602
United States
Northwestern University
Evanston, Illinois, 60201
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
United States
Washington University
St Louis, Missouri, 63110
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Northwell Health
Queens, New York, 11004
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 Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Temple University
Philadelphia, Pennsylvania, 19122
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Martha E Shenton, Ph.D., PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital/Harvard Medical School
  • Scott Woods, M.D., PRINCIPAL_INVESTIGATOR, Yale University
  • Barnaby Nelson, Ph.D., PRINCIPAL_INVESTIGATOR, Center for Youth Mental Health at the University of Melbourne/Orygen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-02
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2022-06-02
Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

  • biomarkers
  • phenotype

Additional Relevant MeSH Terms

  • Clinical High Risk
  • Psychosis
  • Remission
  • Conversion