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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05905003
Registration number
NCT05905003
Ethics application status
Date submitted
17/05/2023
Date registered
15/06/2023
Date last updated
15/06/2023
Titles & IDs
Public title
AMP SCZ® Observational Study: PREDICT-DPACC
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Scientific title
Accelerating Medicines Partnership® Schizophrenia Observational Study: Psychosis Risk Evaluation, Data Integration, and Computational Technologies -Data Processing, Analysis, and Coordination Center and Coordination Center
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Secondary ID [1]
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U24MH124629
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Secondary ID [2]
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2020P002267
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Universal Trial Number (UTN)
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Trial acronym
AMP SCZ
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Clinical High Risk
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Psychosis
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Remission
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Conversion
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Condition category
Condition code
Mental Health
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Psychosis and personality disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
CHR - Clinical High Risk (CHR) for psychosis subjects meeting diagnostic criteria for CHR on the Positive SYmptoms and Diagnostic Criteria for the CAARMS Harmonized with the SIPS (PSYCHS).
HC - Healthy Control (HC) Subjects
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Conversion to Psychosis
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Assessment method [1]
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Conversion to psychosis as defined by psychosis threshold criteria on the PSYCHS.
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Timepoint [1]
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By 24 month follow-up.
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Secondary outcome [1]
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Remission
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Assessment method [1]
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Recovery from CHR as defined by PSYCHS criteria.
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Timepoint [1]
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By 24 month follow-up.
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Secondary outcome [2]
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Non-conversion/Non-remission
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Assessment method [2]
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Continued CHR condition as defined by PSYCHS criteria.
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Timepoint [2]
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By 24 month follow-up.
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Eligibility
Key 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).
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Minimum age
12
Years
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Maximum age
30
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/06/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/05/2025
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Actual
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Sample size
Target
2617
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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HEP and co-located Headspace Adelaide - Adelaide
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Recruitment hospital [2]
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Headspace, Craigieburn - Craigieburn
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Headspace, Glenroy - Glenroy
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Headspace Melton - Melton South
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Orygen Specialist Programs, Melbourne - Parkville
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Headspace, Sunshine - Sunshine
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Headspace, Werribee - Werribee
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3064 - Craigieburn
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Recruitment postcode(s) [3]
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3046 - Glenroy
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Recruitment postcode(s) [4]
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3338 - Melton South
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Recruitment postcode(s) [5]
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3122 - Parkville
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Recruitment postcode(s) [6]
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3020 - Sunshine
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Recruitment postcode(s) [7]
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3030 - Werribee
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Connecticut
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Georgia
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Illinois
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Massachusetts
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Missouri
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New York
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North Carolina
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Pennsylvania
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Canada
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Chile
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China
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Shanghai
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Copenhagen
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Germany
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Brescia
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Germany
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Thuringia
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Germany
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Munich
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Hong Kong
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Italy
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Pavia
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Seoul
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Singapore
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Singapore
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Spain
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Madrid
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Switzerland
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Lausanne
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United Kingdom
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Birmingham
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United Kingdom
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Cambridge
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
Brigham and Women's Hospital
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Orygen
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Other
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Yale University
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Government body
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National Institute of Mental Health (NIMH)
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05905003
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Martha E Shenton, Ph.D.
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Address
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Brigham and Women's Hospital/Harvard Medical School
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Phone
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Email
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Contact person for public queries
Name
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Martha E Shenton, Ph.D.
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Address
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Phone
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617-699-6152
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05905003
Download to PDF