Clinical trial NCT05905003: AMP SCZ® Observational Study: PREDICT-DPACC
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clinical High Risk
Psychosis
Remission
Conversion
Keywords: biomarkers
phenotype
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Orygen
name: Yale University
name: National Institute of Mental Health (NIMH)
First posted: 2023-06-15
Enrollment: 2617
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are recruited and tested at 42 Clinical High Risk research/clinical treatment sites throughout the US, Canada, Australia, Europe, South America, and Asia. The individual sites are part of 2 Research Networks, the Psychosis-Risk Outcomes Network (ProNET) based out of Yale University, and the Trajectories and Predictors in the CHR for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT) based out of the University of Melbourne/Orygen.

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.

Detailed description: The Accelerating Medicines Partnership (AMP®) is a public-private partnership between the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and multiple public and private organizations. The goal of the AMP Schizophrenia (AMP SCZ) program, a multi-continent consortium, is to develop a deep biomarker-informed functional characterization and longitudinal clinical profiling of study participants at clinical high risk (CHR) for psychosis. The data will support the development of algorithms of clinical and biological measures to predict the trajectories and outcomes of CHR individuals to identify enriched CHR patient populations to enable proof of principle intervention studies for early intervention in schizophrenia. These tools will allow the assessment of biomarkers and outcome measures as early indicators of pharmacologic treatment efficacy. See the AMP SCZ website link for a detailed description of study goals (https://www.ampscz.org/about/goals/).

The Accelerating Medicines Partnership® Schizophrenia Observational Study: Psychosis Risk Evaluation, Data Integration, and Computational Technologies Data Processing, Analysis and Coordination Center (AMP SCZ® Observational Study: PREDICT-DPACC) based out of Brigham and Women's Hospital (BWH) and Mass General Brigham (MGB) is one of three research projects supported by the AMP SCZ program.

The AMP SCZ Observational Study: PREDICT-DPACC works with two Clinical High Risk (CHR) research networks (described below) to meet the following goals:

* Capture data from the research networks in a uniform manner.
* Build flexible infrastructure to accommodate multiple data types.
* Develop and refine pipelines that provide rapid data processing (in close to real-time) and quality assurance (QA) and quality control (QC).
* Provide data coordination, management, and monitoring of data.
* Develop powerful and robust stratification tools to identify \& validate biomarkers and predict individual outcome trajectories.
* Assist in archiving data and making it publicly available in the NIMH Data Archive (NDA). Please see (https://nda.nih.gov/ampscz/).
* Disseminate information, including tools developed, to the general research community, and provide outreach to the community via a website.

MGB institutions do not provide or enroll participants for this study but serve as the AMP SCZ DPACC for two CHR Research Networks (RNs) where consent and all clinical testing and data collection occur. MGB is a data recipient only, not a data provider. The Mass General Brigham IRB is the IRB of record for the AMP SCZ® Observational Study: PREDICT-DPACC and the IRB status is exempt.

The two CHR research networks (RNs) that also make up the AMP SCZ program are:

The Psychosis-Risk Outcomes Network (ProNET) is based out of Yale University, which serves as the hub for this network and consists of a network of sites in the US, Canada, Europe, and Asia. Northwell Health is the IRB of record for all US sites in the ProNET RN. All foreign ProNET sites submit to their local IRBs.

The Trajectories and Predictors in the Clinical High Risk for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT), is based out of the Center for Youth Mental Health at the University of Melbourne and at Orygen, Melbourne, Australia, which serves as the hub for this network, and consists of a network of sites in Australia, Europe, and Asia. The Melbourne Health Research Governance and Ethics Office for Research is the IRB of record for all Australian sites in the PRESCIENT research network. European and Asian sites submit to their local IRBs.

Acquisition Sites collect the data and transfer it directly to Brigham and Women's Hospital, which is the main site for the Data Processing Analysis and Coordination Center (DPACC).

See the AMP SCZ website for a searchable map with contact information for all study sites (https://www.ampscz.org/about/map/). Please also see the AMP SCZ website for additional information about the ProNET and PRESCIENT research networks and the PREDICT-DPACC coordination center (https://www.ampscz.org/about/networks-coordination/).

This is a non-interventional study examining clinical trajectories and predictors of outcomes in the CHR population. The CHR cohort and HCs will be assessed with a core set of measures at baseline and 2 months post-baseline, with additional assessments completed at other time points. CHR subjects will be assessed longitudinally for 2 years. Participants who develop first-episode psychosis ('converted' cases) during their study participation will continue to be assessed as scheduled. Measures include clinical, cognitive, neurophysiology, neuroimaging, genetics and fluid biomarkers, speech and facial expression (audio/video recordings are optional), and outcome assessments. Digital assessments such as daily ecological momentary assessment (daily digital diary entries) and passive sensing measurements (actigraphy and geolocation) are optional. See the AMP SCZ website for detailed descriptions of the study design (https://www.ampscz.org/scientists/design/) and protocol (https://www.ampscz.org/wp-content/uploads/2023/01/AMP-SCZ-Protocol-Summary-for-Distribution_24JAN2023.pdf).

Eligibility 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/).

Primary outcomes:
measure: Conversion to Psychosis
timeFrame: By 24 month follow-up.
Secondary outcomes:
measure: Remission
timeFrame: By 24 month follow-up.
measure: Non-conversion/Non-remission
timeFrame: By 24 month follow-up.
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Hartford
country: United States
facility: Hartford Healthcare
state: Connecticut
city: New Haven
country: United States
facility: Yale University/Connecticut Mental Health Center
state: Connecticut
city: Athens
country: United States
facility: University of Georgia
state: Georgia
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Queens
country: United States
facility: Northwell Health
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Adelaide
country: Australia
facility: HEP and co-located Headspace Adelaide
state: South Australia
city: Craigieburn
country: Australia
facility: Headspace, Craigieburn
state: Victoria
city: Glenroy
country: Australia
facility: Headspace, Glenroy
state: Victoria
city: Melton South
country: Australia
facility: Headspace Melton
state: Victoria
city: Parkville
country: Australia
facility: Orygen Specialist Programs, Melbourne
state: Victoria
city: Sunshine
country: Australia
facility: Headspace, Sunshine
state: Victoria
city: Werribee
country: Australia
facility: Headspace, Werribee
state: Victoria
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Montréal
country: Canada
facility: McGill University
state: Quebec
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile (HCUCH)
state: Región Metropolitana
city: Shanghai
country: China
facility: Shanghai Jiao Tong University
city: Copenhagen
country: Denmark
facility: Copenhagen Research Center for Mental Health (CORE)
city: Cologne
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie, University of Cologne
state: Brescia
city: Jena
country: Germany
facility: The University Hospital Jena, Department of Psychiatry
state: Thuringia
city: Munich
country: Germany
facility: Ludwig-Maximilians-Universität Munich
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong, Department of Psychiatry
city: Pavia
country: Italy
facility: University of Pavia
city: Gwangju
country: Korea, Republic of
facility: Department of Psychiatry, Chonnam National University Hospital & Mindlink
city: Seoul
country: Korea, Republic of
facility: Seoul National University College of Medicine
city: Singapore
country: Singapore
facility: Early Psychosis Intervention Programme (EPIP) Clinic, Institute of Mental Health
city: Madrid
country: Spain
facility: Instituto de Psiquiatría y Salud Mental Hospital General Universitario Gregorio Marañón
city: Lausanne
country: Switzerland
facility: Treatment and Early Intervention in Psychosis Program (TIPP) & Center for Psychiatric Neuroscience (CNP), Department of Psychiatry, Lausanne University Hospital
city: Birmingham
country: United Kingdom
facility: Forward Thinking Birmingham
city: Cambridge
country: United Kingdom
facility: University of Cambridge
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: Brigham and Women's Hospital/Harvard Medical School
name: Martha E Shenton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Scott Woods, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Youth Mental Health at the University of Melbourne/Orygen
name: Barnaby Nelson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: