Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program

Abstract Clinical ascertainment and clinical outcome are key features of any large multisite study. In the ProNET and PRESCIENT research networks, the Accelerating Medicines Partnership® Schizophrenia (AMP®SCZ) Clinical Ascertainment and Outcome Measures Team aimed to establish a harmonized clinical...

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Main Authors: Jean Addington, Lu Liu, Amy Braun, Andrea Auther, Monica E. Calkins, Barbara A. Cornblatt, Cheryl M. Corcoran, Paolo Fusar-Poli, Melissa J. Kerr, Catalina V. Mourgues-Codern, Angela R. Nunez, Dominic Oliver, Gregory P. Strauss, Barbara C. Walsh, Luis K. Alameda, Celso Arango, Nicholas J. K. Breitborde, Matthew R. Broome, Kristin S. Cadenhead, Ricardo E. Carrion, Eric Yu Hai Chen, Jimmy Choi, Michael J. Coleman, Philippe Conus, Covadonga M. Diaz-Caneja, Dominic Dwyer, Lauren M. Ellman, Masoomeh Faghankhani, Pablo A. Gaspar, Carla Gerber, Louise Birkedal Glenthøj, Leslie E. Horton, Christy Hui, Grace R. Jacobs, Joseph Kambeitz, Lana Kambeitz-Ilankovic, Matcheri S. Keshavan, Sung-Wan Kim, Nikolaos Koutsouleris, Jun Soo Kwon, Kerstin Langbein, Kathryn E. Lewandowski, Daniel Mamah, Patricia J. Marcy, Daniel H. Mathalon, Vijay A. Mittal, Merete Nordentoft, Godfrey D. Pearlson, Nora Penzel, Jesus Perez, Diana O. Perkins, Albert R. Powers, Jack Rogers, Fred W. Sabb, Jason Schiffman, Jai L. Shah, Steven M. Silverstein, Stefan Smesny, William S. Stone, Andrew Thompson, Judy L. Thompson, Rachel Upthegrove, Swapna Verma, Jijun Wang, Heather M. Wastler, Alana Wickham, Inge Winter-van Rossum, Daniel H. Wolf, Sylvain Bouix, Ofer Pasternak, Rene S. Kahn, Carrie E. Bearden, John M. Kane, Patrick D. McGorry, Kate Buccilli, Barnaby Nelson, Martha E. Shenton, Scott W. Woods, the Accelerating Medicines Partnership® -Schizophrenia, Alison R. Yung
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Language:English
Published: Nature Portfolio 2025-04-01
Series:Schizophrenia
Online Access:https://doi.org/10.1038/s41537-025-00556-7
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author Jean Addington
Lu Liu
Amy Braun
Andrea Auther
Monica E. Calkins
Barbara A. Cornblatt
Cheryl M. Corcoran
Paolo Fusar-Poli
Melissa J. Kerr
Catalina V. Mourgues-Codern
Angela R. Nunez
Dominic Oliver
Gregory P. Strauss
Barbara C. Walsh
Luis K. Alameda
Celso Arango
Nicholas J. K. Breitborde
Matthew R. Broome
Kristin S. Cadenhead
Ricardo E. Carrion
Eric Yu Hai Chen
Jimmy Choi
Michael J. Coleman
Philippe Conus
Covadonga M. Diaz-Caneja
Dominic Dwyer
Lauren M. Ellman
Masoomeh Faghankhani
Pablo A. Gaspar
Carla Gerber
Louise Birkedal Glenthøj
Leslie E. Horton
Christy Hui
Grace R. Jacobs
Joseph Kambeitz
Lana Kambeitz-Ilankovic
Matcheri S. Keshavan
Sung-Wan Kim
Nikolaos Koutsouleris
Jun Soo Kwon
Kerstin Langbein
Kathryn E. Lewandowski
Daniel Mamah
Patricia J. Marcy
Daniel H. Mathalon
Vijay A. Mittal
Merete Nordentoft
Godfrey D. Pearlson
Nora Penzel
Jesus Perez
Diana O. Perkins
Albert R. Powers
Jack Rogers
Fred W. Sabb
Jason Schiffman
Jai L. Shah
Steven M. Silverstein
Stefan Smesny
William S. Stone
Andrew Thompson
Judy L. Thompson
Rachel Upthegrove
Swapna Verma
Jijun Wang
Heather M. Wastler
Alana Wickham
Inge Winter-van Rossum
Daniel H. Wolf
Sylvain Bouix
Ofer Pasternak
Rene S. Kahn
Carrie E. Bearden
John M. Kane
Patrick D. McGorry
Kate Buccilli
Barnaby Nelson
Martha E. Shenton
Scott W. Woods
the Accelerating Medicines Partnership® -Schizophrenia
Alison R. Yung
author_facet Jean Addington
Lu Liu
Amy Braun
Andrea Auther
Monica E. Calkins
Barbara A. Cornblatt
Cheryl M. Corcoran
Paolo Fusar-Poli
Melissa J. Kerr
Catalina V. Mourgues-Codern
Angela R. Nunez
Dominic Oliver
Gregory P. Strauss
Barbara C. Walsh
Luis K. Alameda
Celso Arango
Nicholas J. K. Breitborde
Matthew R. Broome
Kristin S. Cadenhead
Ricardo E. Carrion
Eric Yu Hai Chen
Jimmy Choi
Michael J. Coleman
Philippe Conus
Covadonga M. Diaz-Caneja
Dominic Dwyer
Lauren M. Ellman
Masoomeh Faghankhani
Pablo A. Gaspar
Carla Gerber
Louise Birkedal Glenthøj
Leslie E. Horton
Christy Hui
Grace R. Jacobs
Joseph Kambeitz
Lana Kambeitz-Ilankovic
Matcheri S. Keshavan
Sung-Wan Kim
Nikolaos Koutsouleris
Jun Soo Kwon
Kerstin Langbein
Kathryn E. Lewandowski
Daniel Mamah
Patricia J. Marcy
Daniel H. Mathalon
Vijay A. Mittal
Merete Nordentoft
Godfrey D. Pearlson
Nora Penzel
Jesus Perez
Diana O. Perkins
Albert R. Powers
Jack Rogers
Fred W. Sabb
Jason Schiffman
Jai L. Shah
Steven M. Silverstein
Stefan Smesny
William S. Stone
Andrew Thompson
Judy L. Thompson
Rachel Upthegrove
Swapna Verma
Jijun Wang
Heather M. Wastler
Alana Wickham
Inge Winter-van Rossum
Daniel H. Wolf
Sylvain Bouix
Ofer Pasternak
Rene S. Kahn
Carrie E. Bearden
John M. Kane
Patrick D. McGorry
Kate Buccilli
Barnaby Nelson
Martha E. Shenton
Scott W. Woods
the Accelerating Medicines Partnership® -Schizophrenia
Alison R. Yung
author_sort Jean Addington
collection DOAJ
description Abstract Clinical ascertainment and clinical outcome are key features of any large multisite study. In the ProNET and PRESCIENT research networks, the Accelerating Medicines Partnership® Schizophrenia (AMP®SCZ) Clinical Ascertainment and Outcome Measures Team aimed to establish a harmonized clinical assessment protocol across these two research networks and to define ascertainment criteria and primary and secondary endpoints. In addition to developing the assessment protocol, the goals of this aspect of the AMP SCZ project were: (1) to implement and monitor clinical training, ascertainment of participants, and clinical assessments; (2) to provide expert clinical input to the Psychosis Risk Evaluation, Data Integration and Computational Technologies: Data Processing, Analysis, and Coordination Center (PREDICT-DPACC) for data collection, quality control, and preparation of data for the analysis of the clinical measures; and (3) to provide ongoing support to the collection, analysis, and reporting of clinical data. This paper describes the (1) protocol clinical endpoints and outcomes, (2) rationale for the selection of the clinical measures, (3) extensive training of clinical staff, (4) preparation of clinical measures for a multisite study which includes several sites where English is not the native language; and (5) the assessment of measure stability over time in the AMP SCZ observational study comparing clinical ratings at baseline and at the 2-month follow up. Watch Dr. Jean Addington discuss her work and this article: https://vimeo.com/1040425281 .
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spelling doaj-art-eecd2f9551414721b4ed2ee606eed59f2025-08-20T03:04:51ZengNature PortfolioSchizophrenia2754-69932025-04-0111111010.1038/s41537-025-00556-7Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia ProgramJean Addington0Lu Liu1Amy Braun2Andrea Auther3Monica E. Calkins4Barbara A. Cornblatt5Cheryl M. Corcoran6Paolo Fusar-Poli7Melissa J. Kerr8Catalina V. Mourgues-Codern9Angela R. Nunez10Dominic Oliver11Gregory P. Strauss12Barbara C. Walsh13Luis K. Alameda14Celso Arango15Nicholas J. K. Breitborde16Matthew R. Broome17Kristin S. Cadenhead18Ricardo E. Carrion19Eric Yu Hai Chen20Jimmy Choi21Michael J. Coleman22Philippe Conus23Covadonga M. Diaz-Caneja24Dominic Dwyer25Lauren M. Ellman26Masoomeh Faghankhani27Pablo A. Gaspar28Carla Gerber29Louise Birkedal Glenthøj30Leslie E. Horton31Christy Hui32Grace R. Jacobs33Joseph Kambeitz34Lana Kambeitz-Ilankovic35Matcheri S. Keshavan36Sung-Wan Kim37Nikolaos Koutsouleris38Jun Soo Kwon39Kerstin Langbein40Kathryn E. Lewandowski41Daniel Mamah42Patricia J. Marcy43Daniel H. Mathalon44Vijay A. Mittal45Merete Nordentoft46Godfrey D. Pearlson47Nora Penzel48Jesus Perez49Diana O. Perkins50Albert R. Powers51Jack Rogers52Fred W. Sabb53Jason Schiffman54Jai L. Shah55Steven M. Silverstein56Stefan Smesny57William S. Stone58Andrew Thompson59Judy L. Thompson60Rachel Upthegrove61Swapna Verma62Jijun Wang63Heather M. Wastler64Alana Wickham65Inge Winter-van Rossum66Daniel H. Wolf67Sylvain Bouix68Ofer Pasternak69Rene S. Kahn70Carrie E. Bearden71John M. Kane72Patrick D. McGorry73Kate Buccilli74Barnaby Nelson75Martha E. Shenton76Scott W. Woods77the Accelerating Medicines Partnership® -SchizophreniaAlison R. Yung78Department of Psychiatry, Hotchkiss Brain Institute, University of CalgaryDepartment of Psychiatry, Hotchkiss Brain Institute, University of CalgaryDepartment of Psychiatry, Hotchkiss Brain Institute, University of CalgaryDepartment of Psychiatry, Donald and Barbara Zucker School of MedicineDepartment of Psychiatry, Perelman School of Medicine, University of PennsylvaniaDepartment of Psychiatry, Donald and Barbara Zucker School of MedicineDepartment of Psychiatry, Icahn School of Medicine at Mount SinaiDepartment of Psychosis Studies, King’s CollegeOrygenDepartment of Psychiatry, Yale University School of MedicineDepartment of Psychiatry, Yale University School of MedicineDepartment of Psychosis Studies, King’s CollegeDepartment of Psychology, University of GeorgiaDepartment of Psychiatry, Yale University School of MedicineDepartment of Psychosis Studies, King’s CollegeDepartment of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), CIBERSAM, ISCIII, School of Medicine, Universidad ComplutenseDepartment of Psychiatry and Behavioral Health, Ohio State UniversityInstitute for Mental Health, University of BirminghamUniversity of CaliforniaDepartment of Psychiatry, Donald and Barbara Zucker School of MedicineNanyang Technological University, LKC School of MedicineOlin Neuropsychiatry Research Center, Hartford HealthCare Behavioral Health NetworkDepartment of Psychiatry, Brigham and Women’s Hospital and Harvard Medical SchoolService de Psychiatrie Générale Dép. de Psychiatrie CHUV LausanneDepartment of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), CIBERSAM, ISCIII, School of Medicine, Universidad ComplutenseOrygenDepartment of Psychology & Neuroscience, Temple UniversityDepartment of Psychiatry, Washington University School of MedicineDepartment of Psychiatry, IMHAY, University of ChilePrevention Science Institute, University of OregonCopenhagen Research Centre for Mental Health, Mental Health Copenhagen, Department of Psychology, University of CopenhagenDepartment of Psychiatry, University of Pittsburgh School of MedicineDepartment of Psychiatry, University of Hong KongDepartment of Psychiatry, Brigham and Women’s Hospital and Harvard Medical SchoolUniversity of Cologne, Faculty of Medicine and University Hospital of CologneUniversity of Cologne, Faculty of Medicine and University Hospital of CologneBeth Israel Deaconess Medical Center, Harvard Medical SchoolDepartment of Psychiatry, Chonnam National University Medical SchoolDepartment of Psychosis Studies, King’s CollegeDepartment of Psychiatry, Seoul National University College of MedicineDepartment of Psychiatry and Psychotherapy, Jena University HospitalDepartment of Psychiatry, Brigham and Women’s Hospital and Harvard Medical SchoolDepartment of Psychiatry, Washington University School of MedicineDepartment of Psychiatry, Donald and Barbara Zucker School of MedicineDepartment of Psychiatry and Behavioral Sciences and Weill Institute for Neurosciences, University of California, San FranciscoDepartment of Psychology, Northwestern UniversityMental Health Services in the Capital RegionDepartment of Psychiatry, Yale University School of MedicineDepartment of Psychiatry, Brigham and Women’s Hospital and Harvard Medical SchoolCAMEO, Early Intervention in Psychosis Service, Cambridgeshire and Peterborough NHS Foundation TrustDepartment of Psychiatry, University of North CarolinaDepartment of Psychiatry, Yale University School of MedicineInstitute for Mental Health, University of BirminghamDepartment of Psychiatry, IMHAY, University of ChileDepartment of Psychological Science, University of CaliforniaPEPP-Montreal, Douglas Research CentreDepartment of Psychiatry, University of Rochester Medical CenterDepartment of Psychiatry and Psychotherapy, Jena University HospitalBeth Israel Deaconess Medical Center, Harvard Medical SchoolOrygenDepartment of Psychiatry, University of Rochester Medical CenterEarly Intervention for Psychosis Service, Birmingham Women’s and Children’s NHS Foundation TrustInstitute of Mental HealthShanghai Mental Health Center, Shanghai Jiaotong University School of MedicineDepartment of Psychiatry and Behavioral Health, Ohio State UniversityDepartment of Psychiatry, Brigham and Women’s Hospital and Harvard Medical SchoolDepartment of Psychosis Studies, King’s CollegeDepartment of Psychiatry, Perelman School of Medicine, University of PennsylvaniaDepartment of Psychiatry, Brigham and Women’s Hospital and Harvard Medical SchoolDepartment of Psychiatry, Brigham and Women’s Hospital and Harvard Medical SchoolDepartment of Psychiatry, Icahn School of Medicine at Mount SinaiDepartments of Psychiatry and Biobehavioral Sciences & Psychology, Semel Institute for Neuroscience and Human Behavior, University of CaliforniaDepartment of Psychiatry, Donald and Barbara Zucker School of MedicineOrygenOrygenOrygenDepartment of Psychiatry, Brigham and Women’s Hospital and Harvard Medical SchoolDepartment of Psychiatry, Yale University School of MedicineInstitute of Mental and Physical Health and Clinical Translation (IMPACT), Deakin UniversityAbstract Clinical ascertainment and clinical outcome are key features of any large multisite study. In the ProNET and PRESCIENT research networks, the Accelerating Medicines Partnership® Schizophrenia (AMP®SCZ) Clinical Ascertainment and Outcome Measures Team aimed to establish a harmonized clinical assessment protocol across these two research networks and to define ascertainment criteria and primary and secondary endpoints. In addition to developing the assessment protocol, the goals of this aspect of the AMP SCZ project were: (1) to implement and monitor clinical training, ascertainment of participants, and clinical assessments; (2) to provide expert clinical input to the Psychosis Risk Evaluation, Data Integration and Computational Technologies: Data Processing, Analysis, and Coordination Center (PREDICT-DPACC) for data collection, quality control, and preparation of data for the analysis of the clinical measures; and (3) to provide ongoing support to the collection, analysis, and reporting of clinical data. This paper describes the (1) protocol clinical endpoints and outcomes, (2) rationale for the selection of the clinical measures, (3) extensive training of clinical staff, (4) preparation of clinical measures for a multisite study which includes several sites where English is not the native language; and (5) the assessment of measure stability over time in the AMP SCZ observational study comparing clinical ratings at baseline and at the 2-month follow up. Watch Dr. Jean Addington discuss her work and this article: https://vimeo.com/1040425281 .https://doi.org/10.1038/s41537-025-00556-7
spellingShingle Jean Addington
Lu Liu
Amy Braun
Andrea Auther
Monica E. Calkins
Barbara A. Cornblatt
Cheryl M. Corcoran
Paolo Fusar-Poli
Melissa J. Kerr
Catalina V. Mourgues-Codern
Angela R. Nunez
Dominic Oliver
Gregory P. Strauss
Barbara C. Walsh
Luis K. Alameda
Celso Arango
Nicholas J. K. Breitborde
Matthew R. Broome
Kristin S. Cadenhead
Ricardo E. Carrion
Eric Yu Hai Chen
Jimmy Choi
Michael J. Coleman
Philippe Conus
Covadonga M. Diaz-Caneja
Dominic Dwyer
Lauren M. Ellman
Masoomeh Faghankhani
Pablo A. Gaspar
Carla Gerber
Louise Birkedal Glenthøj
Leslie E. Horton
Christy Hui
Grace R. Jacobs
Joseph Kambeitz
Lana Kambeitz-Ilankovic
Matcheri S. Keshavan
Sung-Wan Kim
Nikolaos Koutsouleris
Jun Soo Kwon
Kerstin Langbein
Kathryn E. Lewandowski
Daniel Mamah
Patricia J. Marcy
Daniel H. Mathalon
Vijay A. Mittal
Merete Nordentoft
Godfrey D. Pearlson
Nora Penzel
Jesus Perez
Diana O. Perkins
Albert R. Powers
Jack Rogers
Fred W. Sabb
Jason Schiffman
Jai L. Shah
Steven M. Silverstein
Stefan Smesny
William S. Stone
Andrew Thompson
Judy L. Thompson
Rachel Upthegrove
Swapna Verma
Jijun Wang
Heather M. Wastler
Alana Wickham
Inge Winter-van Rossum
Daniel H. Wolf
Sylvain Bouix
Ofer Pasternak
Rene S. Kahn
Carrie E. Bearden
John M. Kane
Patrick D. McGorry
Kate Buccilli
Barnaby Nelson
Martha E. Shenton
Scott W. Woods
the Accelerating Medicines Partnership® -Schizophrenia
Alison R. Yung
Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program
Schizophrenia
title Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program
title_full Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program
title_fullStr Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program
title_full_unstemmed Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program
title_short Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program
title_sort sample ascertainment and clinical outcome measures in the accelerating medicines partnership r schizophrenia program
url https://doi.org/10.1038/s41537-025-00556-7
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