Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05905003
Status:
RECRUITING
Last Update Posted:
2023-06-15
First Post:
2023-05-17
Brief Title:
AMP SCZ Observational Study PREDICT-DPACC
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMP SCZ
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 andor 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 n1977 and healthy control HC participants n640 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
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 n1977 and healthy control HC participants n640 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 US 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 httpswwwampsczorgaboutgoals
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 Womens 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 httpsndanihgovampscz
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 Womens 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 httpswwwampsczorgaboutmap Please also see the AMP SCZ website for additional information about the ProNET and PRESCIENT research networks and the PREDICT-DPACC coordination center httpswwwampsczorgaboutnetworks-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 audiovideo 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 httpswwwampsczorgscientistsdesign and protocol httpswwwampsczorgwp-contentuploads202301AMP-SCZ-Protocol-Summary-for-Distribution_24JAN2023pdf
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 Womens 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 httpsndanihgovampscz
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 Womens 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 httpswwwampsczorgaboutmap Please also see the AMP SCZ website for additional information about the ProNET and PRESCIENT research networks and the PREDICT-DPACC coordination center httpswwwampsczorgaboutnetworks-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 audiovideo 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 httpswwwampsczorgscientistsdesign and protocol httpswwwampsczorgwp-contentuploads202301AMP-SCZ-Protocol-Summary-for-Distribution_24JAN2023pdf
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U24MH124629 | NIH | None | None |
| U01MH124631 | NIH | None | None |
| U01MH124639 | NIH | None | httpsreporternihgovquickSearchU01MH124639 |