Schizophrenia (Apr 2025)
Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program
- 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
Affiliations
- Jean Addington
- Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary
- Lu Liu
- Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary
- Amy Braun
- Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary
- Andrea Auther
- Department of Psychiatry, Donald and Barbara Zucker School of Medicine
- Monica E. Calkins
- Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania
- Barbara A. Cornblatt
- Department of Psychiatry, Donald and Barbara Zucker School of Medicine
- Cheryl M. Corcoran
- Department of Psychiatry, Icahn School of Medicine at Mount Sinai
- Paolo Fusar-Poli
- Department of Psychosis Studies, King’s College
- Melissa J. Kerr
- Orygen
- Catalina V. Mourgues-Codern
- Department of Psychiatry, Yale University School of Medicine
- Angela R. Nunez
- Department of Psychiatry, Yale University School of Medicine
- Dominic Oliver
- Department of Psychosis Studies, King’s College
- Gregory P. Strauss
- Department of Psychology, University of Georgia
- Barbara C. Walsh
- Department of Psychiatry, Yale University School of Medicine
- Luis K. Alameda
- Department of Psychosis Studies, King’s College
- Celso Arango
- Department 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 Complutense
- Nicholas J. K. Breitborde
- Department of Psychiatry and Behavioral Health, Ohio State University
- Matthew R. Broome
- Institute for Mental Health, University of Birmingham
- Kristin S. Cadenhead
- University of California
- Ricardo E. Carrion
- Department of Psychiatry, Donald and Barbara Zucker School of Medicine
- Eric Yu Hai Chen
- Nanyang Technological University, LKC School of Medicine
- Jimmy Choi
- Olin Neuropsychiatry Research Center, Hartford HealthCare Behavioral Health Network
- Michael J. Coleman
- Department of Psychiatry, Brigham and Women’s Hospital and Harvard Medical School
- Philippe Conus
- Service de Psychiatrie Générale Dép. de Psychiatrie CHUV Lausanne
- Covadonga M. Diaz-Caneja
- Department 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 Complutense
- Dominic Dwyer
- Orygen
- Lauren M. Ellman
- Department of Psychology & Neuroscience, Temple University
- Masoomeh Faghankhani
- Department of Psychiatry, Washington University School of Medicine
- Pablo A. Gaspar
- Department of Psychiatry, IMHAY, University of Chile
- Carla Gerber
- Prevention Science Institute, University of Oregon
- Louise Birkedal Glenthøj
- Copenhagen Research Centre for Mental Health, Mental Health Copenhagen, Department of Psychology, University of Copenhagen
- Leslie E. Horton
- Department of Psychiatry, University of Pittsburgh School of Medicine
- Christy Hui
- Department of Psychiatry, University of Hong Kong
- Grace R. Jacobs
- Department of Psychiatry, Brigham and Women’s Hospital and Harvard Medical School
- Joseph Kambeitz
- University of Cologne, Faculty of Medicine and University Hospital of Cologne
- Lana Kambeitz-Ilankovic
- University of Cologne, Faculty of Medicine and University Hospital of Cologne
- Matcheri S. Keshavan
- Beth Israel Deaconess Medical Center, Harvard Medical School
- Sung-Wan Kim
- Department of Psychiatry, Chonnam National University Medical School
- Nikolaos Koutsouleris
- Department of Psychosis Studies, King’s College
- Jun Soo Kwon
- Department of Psychiatry, Seoul National University College of Medicine
- Kerstin Langbein
- Department of Psychiatry and Psychotherapy, Jena University Hospital
- Kathryn E. Lewandowski
- Department of Psychiatry, Brigham and Women’s Hospital and Harvard Medical School
- Daniel Mamah
- Department of Psychiatry, Washington University School of Medicine
- Patricia J. Marcy
- Department of Psychiatry, Donald and Barbara Zucker School of Medicine
- Daniel H. Mathalon
- Department of Psychiatry and Behavioral Sciences and Weill Institute for Neurosciences, University of California, San Francisco
- Vijay A. Mittal
- Department of Psychology, Northwestern University
- Merete Nordentoft
- Mental Health Services in the Capital Region
- Godfrey D. Pearlson
- Department of Psychiatry, Yale University School of Medicine
- Nora Penzel
- Department of Psychiatry, Brigham and Women’s Hospital and Harvard Medical School
- Jesus Perez
- CAMEO, Early Intervention in Psychosis Service, Cambridgeshire and Peterborough NHS Foundation Trust
- Diana O. Perkins
- Department of Psychiatry, University of North Carolina
- Albert R. Powers
- Department of Psychiatry, Yale University School of Medicine
- Jack Rogers
- Institute for Mental Health, University of Birmingham
- Fred W. Sabb
- Department of Psychiatry, IMHAY, University of Chile
- Jason Schiffman
- Department of Psychological Science, University of California
- Jai L. Shah
- PEPP-Montreal, Douglas Research Centre
- Steven M. Silverstein
- Department of Psychiatry, University of Rochester Medical Center
- Stefan Smesny
- Department of Psychiatry and Psychotherapy, Jena University Hospital
- William S. Stone
- Beth Israel Deaconess Medical Center, Harvard Medical School
- Andrew Thompson
- Orygen
- Judy L. Thompson
- Department of Psychiatry, University of Rochester Medical Center
- Rachel Upthegrove
- Early Intervention for Psychosis Service, Birmingham Women’s and Children’s NHS Foundation Trust
- Swapna Verma
- Institute of Mental Health
- Jijun Wang
- Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine
- Heather M. Wastler
- Department of Psychiatry and Behavioral Health, Ohio State University
- Alana Wickham
- Department of Psychiatry, Brigham and Women’s Hospital and Harvard Medical School
- Inge Winter-van Rossum
- Department of Psychosis Studies, King’s College
- Daniel H. Wolf
- Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania
- Sylvain Bouix
- Department of Psychiatry, Brigham and Women’s Hospital and Harvard Medical School
- Ofer Pasternak
- Department of Psychiatry, Brigham and Women’s Hospital and Harvard Medical School
- Rene S. Kahn
- Department of Psychiatry, Icahn School of Medicine at Mount Sinai
- Carrie E. Bearden
- Departments of Psychiatry and Biobehavioral Sciences & Psychology, Semel Institute for Neuroscience and Human Behavior, University of California
- John M. Kane
- Department of Psychiatry, Donald and Barbara Zucker School of Medicine
- Patrick D. McGorry
- Orygen
- Kate Buccilli
- Orygen
- Barnaby Nelson
- Orygen
- Martha E. Shenton
- Department of Psychiatry, Brigham and Women’s Hospital and Harvard Medical School
- Scott W. Woods
- Department of Psychiatry, Yale University School of Medicine
- the Accelerating Medicines Partnership® -Schizophrenia
- Alison R. Yung
- Institute of Mental and Physical Health and Clinical Translation (IMPACT), Deakin University
- DOI
- https://doi.org/10.1038/s41537-025-00556-7
- Journal volume & issue
-
Vol. 11,
no. 1
pp. 1 – 10
Abstract
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 .