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

Jean Addington¹, Lu Liu², Amy Braun², Andrea Auther^{3

4}, Monica E Calkins⁵, Barbara A Cornblatt^{3

4}, Cheryl M Corcoran⁶, Paolo Fusar-Poli^{7

8}, Melissa J Kerr^{9

10}, Catalina V Mourgues-Codern^{11

12}, Angela R Nunez^{11

12}, Dominic Oliver⁷, Gregory P Strauss¹³, Barbara C Walsh^{11

12}, Luis K Alameda^{7

14}, Celso Arango¹⁵, Nicholas J K Breitborde^{16

17}, Matthew R Broome^{18

19}, Kristin S Cadenhead²⁰, Ricardo E Carrion^{3

4}, Eric Yu Hai Chen²¹, Jimmy Choi²², Michael J Coleman²³, Philippe Conus¹⁴, Covadonga M Diaz-Caneja¹⁵, Dominic Dwyer^{9

10}, Lauren M Ellman²⁴, Masoomeh Faghankhani²⁵, Pablo A Gaspar²⁶, Carla Gerber²⁷, Louise Birkedal Glenthøj²⁸, Leslie E Horton²⁹, Christy Hui³⁰, Grace R Jacobs²³, Joseph Kambeitz³¹, Lana Kambeitz-Ilankovic³¹, Matcheri S Keshavan³², Sung-Wan Kim^{33

34}, Nikolaos Koutsouleris^{7

35}, Jun Soo Kwon³⁶, Kerstin Langbein³⁷, Kathryn E Lewandowski²³, Daniel Mamah²⁵, Patricia J Marcy³, Daniel H Mathalon^{38

39}, Vijay A Mittal⁴⁰, Merete Nordentoft^{41

42}, Godfrey D Pearlson^{11

22}, Nora Penzel²³, Jesus Perez^{43

44}, Diana O Perkins⁴⁵, Albert R Powers 3rd^{11

12}, Jack Rogers^{18

46}, Fred W Sabb²⁶, Jason Schiffman⁴⁷, Jai L Shah^{48

49}, Steven M Silverstein⁵⁰, Stefan Smesny³⁷, William S Stone³², Andrew Thompson^{9

10}, Judy L Thompson⁵⁰, Rachel Upthegrove¹⁹, Swapna Verma⁵¹, Jijun Wang⁵², Heather M Wastler^{16

17}, Alana Wickham²³, Inge Winter-van Rossum⁷, Daniel H Wolf⁵, Sylvain Bouix^{23

53}, Ofer Pasternak^{23

54}, Rene S Kahn⁶, Carrie E Bearden⁵⁵, John M Kane^{3

4}, Patrick D McGorry^{9

10}, Kate Buccilli^{9

10}, Barnaby Nelson^{9

10}, Martha E Shenton²³, Scott W Woods^{11

12}; Accelerating Medicines Partnership® -Schizophrenia; Alison R Yung^{56

57}

Affiliations

¹ Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. jmadding@ucalgary.ca.
² Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.
³ Department of Psychiatry, Donald and Barbara Zucker School of Medicine, Hempstead, NY, USA.
⁴ Institute of Behavioral Science, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY, USA.
⁵ Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
⁶ Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁷ Department of Psychosis Studies, King's College, London, UK.
⁸ Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.
⁹ Orygen, Parkville, VIC, Australia.
¹⁰ Centre for Youth Mental Health, The University of Melbourne, Parkville, VIC, Australia.
¹¹ Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
¹² Connecticut Mental Health Center, New Haven, CT, USA.
¹³ Department of Psychology, University of Georgia, Athens, GA, USA.
¹⁴ Service de Psychiatrie Générale Dép. de Psychiatrie CHUV Lausanne, Lausanne, Switzerland.
¹⁵ 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, Madrid, Spain.
¹⁶ Department of Psychiatry and Behavioral Health, Ohio State University, Columbus, OH, USA.
¹⁷ Department of Psychology, Ohio State University, Columbus, OH, USA.
¹⁸ Institute for Mental Health, University of Birmingham, Birmingham, UK.
¹⁹ Early Intervention for Psychosis Service, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.
²⁰ University of California, San Diego, CA, USA.
²¹ Nanyang Technological University, LKC School of Medicine, Nanyang, Singapore.
²² Olin Neuropsychiatry Research Center, Hartford HealthCare Behavioral Health Network, Hartford, CT, USA.
²³ Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
²⁴ Department of Psychology & Neuroscience, Temple University, Philadelphia, PA, USA.
²⁵ Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.
²⁶ Department of Psychiatry, IMHAY, University of Chile, Santiago, Chile.
²⁷ Prevention Science Institute, University of Oregon, Eugene, OR, USA.
²⁸ Copenhagen Research Centre for Mental Health, Mental Health Copenhagen, Department of Psychology, University of Copenhagen, Copenhagen, Denmark.
²⁹ Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
³⁰ Department of Psychiatry, University of Hong Kong, Hong Kong, China.
³¹ University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.
³² Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
³³ Department of Psychiatry, Chonnam National University Medical School, Gwangju, South Korea.
³⁴ Mindlink, Gwangju Bukgu Mental Health Center, Gwangju, South Korea.
³⁵ Department of Psychiatry and Psychotherapy, Ludwig-Maximilian-University Munich, Munich, Germany.
³⁶ Department of Psychiatry, Seoul National University College of Medicine, Seoul, South Korea.
³⁷ Department of Psychiatry and Psychotherapy, Jena University Hospital, Jena, Germany.
³⁸ Department of Psychiatry and Behavioral Sciences and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, USA.
³⁹ Mental Health Service 116D, Veterans Affairs San Francisco Health Care System, San Francisco, CA, USA.
⁴⁰ Department of Psychology, Northwestern University, Chicago, IL, USA.
⁴¹ Mental Health Services in the Capital Region, Copenhagen, Denmark.
⁴² Department of Clinical Medicine, Copenhagen University Hospital, Copenhagen, Denmark.
⁴³ CAMEO, Early Intervention in Psychosis Service, Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK.
⁴⁴ Department of Medicine, Institute of Biomedical Research (IBSAL), Universidad de Salamanca, Salamanca, Spain.
⁴⁵ Department of Psychiatry, University of North Carolina, Chapel Hill, NC, USA.
⁴⁶ Centre for Human Brain Health, University of Birmingham, Birmingham, UK.
⁴⁷ Department of Psychological Science, University of California, Irvine, CA, USA.
⁴⁸ PEPP-Montreal, Douglas Research Centre, Montreal, QC, Canada.
⁴⁹ Department of Psychiatry, McGill University, Montreal, QC, Canada.
⁵⁰ Department of Psychiatry, University of Rochester Medical Center, Rochester, NY, USA.
⁵¹ Institute of Mental Health, Singapore, Singapore.
⁵² Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai, China.
⁵³ Department of Software Engineering and Information Technology, École de technologie supérieure, Montréal, QC, Canada.
⁵⁴ Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
⁵⁵ Departments of Psychiatry and Biobehavioral Sciences & Psychology, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.
⁵⁶ Institute of Mental and Physical Health and Clinical Translation (IMPACT), Deakin University, Geelong, VIC, Australia.
⁵⁷ School of Health Sciences, University of Manchester, Manchester, UK.

PMID: 40180953
PMCID: PMC11968923
DOI: 10.1038/s41537-025-00556-7

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

Jean Addington et al. Schizophrenia (Heidelb). 2025.

. 2025 Apr 3;11(1):54.

doi: 10.1038/s41537-025-00556-7.

Authors

Affiliations

¹ Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. jmadding@ucalgary.ca.
² Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.
³ Department of Psychiatry, Donald and Barbara Zucker School of Medicine, Hempstead, NY, USA.
⁴ Institute of Behavioral Science, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY, USA.
⁵ Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
⁶ Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁷ Department of Psychosis Studies, King's College, London, UK.
⁸ Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.
⁹ Orygen, Parkville, VIC, Australia.
¹⁰ Centre for Youth Mental Health, The University of Melbourne, Parkville, VIC, Australia.
¹¹ Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
¹² Connecticut Mental Health Center, New Haven, CT, USA.
¹³ Department of Psychology, University of Georgia, Athens, GA, USA.
¹⁴ Service de Psychiatrie Générale Dép. de Psychiatrie CHUV Lausanne, Lausanne, Switzerland.
¹⁵ 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, Madrid, Spain.
¹⁶ Department of Psychiatry and Behavioral Health, Ohio State University, Columbus, OH, USA.
¹⁷ Department of Psychology, Ohio State University, Columbus, OH, USA.
¹⁸ Institute for Mental Health, University of Birmingham, Birmingham, UK.
¹⁹ Early Intervention for Psychosis Service, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.
²⁰ University of California, San Diego, CA, USA.
²¹ Nanyang Technological University, LKC School of Medicine, Nanyang, Singapore.
²² Olin Neuropsychiatry Research Center, Hartford HealthCare Behavioral Health Network, Hartford, CT, USA.
²³ Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
²⁴ Department of Psychology & Neuroscience, Temple University, Philadelphia, PA, USA.
²⁵ Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.
²⁶ Department of Psychiatry, IMHAY, University of Chile, Santiago, Chile.
²⁷ Prevention Science Institute, University of Oregon, Eugene, OR, USA.
²⁸ Copenhagen Research Centre for Mental Health, Mental Health Copenhagen, Department of Psychology, University of Copenhagen, Copenhagen, Denmark.
²⁹ Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
³⁰ Department of Psychiatry, University of Hong Kong, Hong Kong, China.
³¹ University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.
³² Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
³³ Department of Psychiatry, Chonnam National University Medical School, Gwangju, South Korea.
³⁴ Mindlink, Gwangju Bukgu Mental Health Center, Gwangju, South Korea.
³⁵ Department of Psychiatry and Psychotherapy, Ludwig-Maximilian-University Munich, Munich, Germany.
³⁶ Department of Psychiatry, Seoul National University College of Medicine, Seoul, South Korea.
³⁷ Department of Psychiatry and Psychotherapy, Jena University Hospital, Jena, Germany.
³⁸ Department of Psychiatry and Behavioral Sciences and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, USA.
³⁹ Mental Health Service 116D, Veterans Affairs San Francisco Health Care System, San Francisco, CA, USA.
⁴⁰ Department of Psychology, Northwestern University, Chicago, IL, USA.
⁴¹ Mental Health Services in the Capital Region, Copenhagen, Denmark.
⁴² Department of Clinical Medicine, Copenhagen University Hospital, Copenhagen, Denmark.
⁴³ CAMEO, Early Intervention in Psychosis Service, Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK.
⁴⁴ Department of Medicine, Institute of Biomedical Research (IBSAL), Universidad de Salamanca, Salamanca, Spain.
⁴⁵ Department of Psychiatry, University of North Carolina, Chapel Hill, NC, USA.
⁴⁶ Centre for Human Brain Health, University of Birmingham, Birmingham, UK.
⁴⁷ Department of Psychological Science, University of California, Irvine, CA, USA.
⁴⁸ PEPP-Montreal, Douglas Research Centre, Montreal, QC, Canada.
⁴⁹ Department of Psychiatry, McGill University, Montreal, QC, Canada.
⁵⁰ Department of Psychiatry, University of Rochester Medical Center, Rochester, NY, USA.
⁵¹ Institute of Mental Health, Singapore, Singapore.
⁵² Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai, China.
⁵³ Department of Software Engineering and Information Technology, École de technologie supérieure, Montréal, QC, Canada.
⁵⁴ Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
⁵⁵ Departments of Psychiatry and Biobehavioral Sciences & Psychology, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.
⁵⁶ Institute of Mental and Physical Health and Clinical Translation (IMPACT), Deakin University, Geelong, VIC, Australia.
⁵⁷ School of Health Sciences, University of Manchester, Manchester, UK.

PMID: 40180953
PMCID: PMC11968923
DOI: 10.1038/s41537-025-00556-7

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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Conflict of interest statement

Competing interests: Dr A. Thomson has received honorarium and/or grants from Ostuka, Boehringer, Eli Lilly, Janssen Cilag, Lundbeck, Pfizer and Sunovion. Dr C. Arango has been a consultant to and/or has received honorarium and or grants from Acadia, Angelini, Biogen, Boehringer, Gideon Richter, Janssen Cilag, Lundbeck, Medscape, Menarini, Minerva, Otsuka, Pfizer, Roche, Sage, Servier, Shire, Shering Plough, Sumitomo Dainippon Pharma, Sunovian and Takeda. Dr R. Upthegrove has received speaker fees for Otsuka and consulted to Viatris and Springer Healthcare. Dr P. Fusar-Poli has received research funds or personal fees from Angelini, Boehringer, Lundbeck, Menarini, Otsuka, Sunovian and Poxymm Science. Dr. S. Woods has received speaking fees from the American Psychiatric Association and from Medscape Features. He has been granted US patent no. 8492418 B2 for a method of treating prodromal schizophrenia with glycine agonists. He owns stock in NW PharmaTech. Dr C Diaz-Caneja has received grant support from Instituto de Salud Carlos III, Spanish Ministry of Science and Innovation and honoraria or travel support from Angelini, Janssen, and Viatris. Dr Dwyer has received honorary funds for one educational seminar for CSL Sequiris. Dr. Kambeitz has received speaking or consulting fees from Janssen, Boehringer Ingelheim, ROVI and Lundbeck. Patricia J. Marcy is a consultant for Otsuka and TEVA. Dr R S. Kahn is a consultant for Alkermes, Boehringer-Ingelheim. Dr. M. KaneConsultant to or receives honoraria and/or travel support and/or speakers bureau: Alkermes, Allergan, Boehringer-Ingelheim, Cerevel, Dainippon Sumitomo, H. Lundbeck, HealthRhythms, HLS Therapeutics, Indivior, Intracellular Therapies, Janssen Pharmaceutical, Johnson & Johnson, Karuna Therapeutics/Bristol Meyer-Squibb, LB Pharmaceuticals, Mapi, Maplight, Merck, Minerva, Neurocrine, Newron, Novartis, NW PharmaTech, Otsuka, Roche, Saladax, Sunovion, Teva Advisory Boards: Alkermes, Boehringer-Ingelheim, Cerevel, Click Therapeutics, Karuna/BMS, Lundbeck, Merck, Newron, Novartis, Otsuka, Sumitomo, Teva, Terran Grant Support: Lundbeck, Janssen, Otsuka, Sunovion and has Shareholder interests in Cerevel (public/stock), HealthRhythms (private/stock options), Karuna/BMS (public), LB Pharmaceuticals, Inc. (private/stock options), North Shore Therapeutics (private/stock), Vanguard Research Group (private/40% owner). All other authors report no competing interests.

References

1. Wannan, C. M. et al. Accelerating medicines partnership® Schizophrenia (AMP® SCZ): rationale and study design of the largest global prospective cohort study of clinical high risk for psychosis. Schizophr. Bull.50(3), 496–512 (2024). - PMC - PubMed
1. Brady, L. S., Larrauri, C. A. & Committee, A. S. S. Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ): developing tools to enable early intervention in the psychosis high risk state. World Psychiatry22, 42–43 (2023). - PMC - PubMed
1. Benrimoh, D. et al. On the proportion of patients who experience a prodrome prior to psychosis onset: a systematic review and meta-analysis. Mol. Psychiatry29, 1361–1381 (2024). - PubMed
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1. McGlashan, T., Walsh, B. & Woods, S. The psychosis-risk syndrome: Handbook for diagnosis and follow-up (Oxford University Press, 2010).

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

References

Grants and funding

LinkOut - more resources

Full Text Sources