Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ): Rationale and Study Design of the Largest Global Prospective Cohort Study of Clinical High Risk for Psychosis

Author:

Wannan Cassandra M J12,Nelson Barnaby12,Addington Jean3,Allott Kelly12ORCID,Anticevic Alan45,Arango Celso6,Baker Justin T7,Bearden Carrie E89ORCID,Billah Tashrif10,Bouix Sylvain11,Broome Matthew R1213,Buccilli Kate12,Cadenhead Kristin S14ORCID,Calkins Monica E15ORCID,Cannon Tyrone D416,Cecci Guillermo17ORCID,Chen Eric Yu Hai18,Cho Kang Ik K9,Choi Jimmy19,Clark Scott R2021,Coleman Michael J9,Conus Philippe22,Corcoran Cheryl M23,Cornblatt Barbara A2425,Diaz-Caneja Covadonga M6ORCID,Dwyer Dominic12ORCID,Ebdrup Bjørn H26,Ellman Lauren M27,Fusar-Poli Paolo2829,Galindo Liliana3031,Gaspar Pablo A32,Gerber Carla33,Glenthøj Louise Birkedal3435,Glynn Robert3637,Harms Michael P38,Horton Leslie E39,Kahn René S23,Kambeitz Joseph40ORCID,Kambeitz-Ilankovic Lana40,Kane John M2425ORCID,Kapur Tina41,Keshavan Matcheri S42,Kim Sung-Wan4344ORCID,Koutsouleris Nikolaos45,Kubicki Marek946,Kwon Jun Soo4748ORCID,Langbein Kerstin49,Lewandowski Kathryn E7,Light Gregory A1450,Mamah Daniel51,Marcy Patricia J52,Mathalon Daniel H5354,McGorry Patrick D12,Mittal Vijay A55ORCID,Nordentoft Merete3456,Nunez Angela45,Pasternak Ofer946,Pearlson Godfrey D419,Perez Jesus5758,Perkins Diana O59,Powers Albert R45ORCID,Roalf David R15,Sabb Fred W60,Schiffman Jason61,Shah Jai L6263,Smesny Stefan49,Spark Jessica12,Stone William S42ORCID,Strauss Gregory P64,Tamayo Zailyn45,Torous John43ORCID,Upthegrove Rachel1165,Vangel Mark66,Verma Swapna67,Wang Jijun68,Rossum Inge Winter-van25,Wolf Daniel H15,Wolff Phillip69,Wood Stephen J1270,Yung Alison R7172,Agurto Carla17,Alvarez-Jimenez Mario12,Amminger Paul12,Armando Marco73,Asgari-Targhi Ameneh41,Cahill John45,Carrión Ricardo E2425,Castro Eduardo17,Cetin-Karayumak Suheyla9,Mallar Chakravarty M63,Cho Youngsun T45,Cotter David7475,D’Alfonso Simon76,Ennis Michaela7ORCID,Fadnavis Shreyas9,Fonteneau Clara45,Gao Caroline12ORCID,Gupta Tina39,Gur Raquel E15,Gur Ruben C15,Hamilton Holly K10,Hoftman Gil D89,Jacobs Grace R10,Jarcho Johanna27,Ji Jie Lisa45,Kohler Christian G15,Lalousis Paris Alexandros1277,Lavoie Suzie12,Lepage Martin63,Liebenthal Einat78,Mervis Josh27,Murty Vishnu27,Nicholas Spero C51,Ning Lipeng941,Penzel Nora9,Poldrack Russell79,Polosecki Pablo17,Pratt Danielle N55,Rabin Rachel62,Rahimi Eichi Habiballah7,Rathi Yogesh1041,Reichenberg Avraham23,Reinen Jenna17,Rogers Jack77,Ruiz-Yu Bernalyn8,Scott Isabelle12,Seitz-Holland Johanna10,Srihari Vinod H478,Srivastava Agrima23,Thompson Andrew12,Turetsky Bruce I15,Walsh Barbara C45,Whitford Thomas280,Wigman Johanna T W81,Yao Beier7,Yuen Hok Pan12,Ahmed Uzair2,Byun Andrew (Jin Soo)8283,Chung Yoonho7,Do Kim8485,Hendricks Larry12,Huynh Kevin12,Jeffries Clark86,Lane Erlend42,Langholm Carsten42,Lin Eric78788,Mantua Valentina89,Santorelli Gennarina43,Ruparel Kosha16,Zoupou Eirini16,Adasme Tatiana32,Addamo Lauren12,Adery Laura89,Ali Munaza45,Auther Andrea24,Aversa Samantha62,Baek Seon-Hwa4344,Bates Kelly55,Bathery Alyssa89,Bayer Johanna M M12,Beedham Rebecca12,Bilgrami Zarina69,Birch Sonia12,Bonoldi Ilaria2829,Borders Owen10,Borgatti Renato2990,Brown Lisa41,Bruna Alejandro32,Carrington Holly10,Castillo-Passi Rolando I3291,Chen Justine10,Cheng Nicholas12,Ching Ann Ee12,Clifford Chloe12,Colton Beau-Luke12,Contreras Pamela32,Corral Sebastián32,Damiani Stefano29,Done Monica89,Estradé Andrés92,Etuka Brandon Asika4,Formica Melanie12,Furlan Rachel27,Geljic Mia12,Germano Carmela12,Getachew Ruth12,Goncalves Mathias79,Haidar Anastasia10,Hartmann Jessica93,Jo Anna43,John Omar10,Kerins Sarah92,Kerr Melissa12,Kesselring Irena89,Kim Honey43,Kim Nicholas10,Kinney Kyle27,Krcmar Marija12,Kotler Elana10,Lafanechere Melanie7077,Lee Clarice12,Llerena Joshua12,Markiewicz Christopher79,Matnejl Priya52,Maturana Alejandro32,Mavambu Aissata12,Mayol-Troncoso Rocío32,McDonnell Amelia27,McGowan Alessia23,McLaughlin Danielle52,McIlhenny Rebecca39,McQueen Brittany12,Mebrahtu Yohannes12,Mensi Martina2990,Hui Christy Lai Ming18,Suen Yi Nam18,Wong Stephanie Ming Yin18,Morrell Neal12,Omar Mariam12,Partridge Alice12,Phassouliotis Christina12,Pichiecchio Anna2994,Politi Pierluigi29,Porter Christian39,Provenzani Umberto29,Prunier Nicholas10,Raj Jasmine55,Ray Susan52,Rayner Victoria12,Reyes Manuel3291,Reynolds Kate12,Rush Sage89,Salinas Cesar32,Shetty Jashmina12,Snowball Callum12,Tod Sophie12,Turra-Fariña Gabriel32,Valle Daniela32,Veale Simone10,Whitson Sarah12,Wickham Alana10,Youn Sarah12,Zamorano Francisco9596,Zavaglia Elissa62,Zinberg Jamie89,Woods Scott W45,Shenton Martha E104146

Affiliation:

1. Centre for Youth Mental Health, The University of Melbourne , Parkville, VIC , Australia

2. Orygen , Parkville, VIC , Australia

3. Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary , Calgary, AB , Canada

4. Department of Psychiatry, Yale University School of Medicine , New Haven, CT , USA

5. Connecticut Mental Health Center , New Haven, CT , USA

6. Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, IiSGM, CIBERSAM, Instituto de Salud Carlos III, School of Medicine, Universidad Complutense , Madrid , Spain

7. Department of Psychiatry, McLean Hospital and Harvard Medical School , Boston, MA , USA

8. Department of Psychiatry, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles , Los Angeles, CA , USA

9. Department Biobehavioral Sciences and Psychology, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles , Los Angeles, CA , USA

10. Department of Psychiatry, Brigham and Women’s Hospital and Harvard Medical School , Boston, MA , USA

11. Department of Software Engineering and Information Technology, École de technologie supérieure , Montréal , Canada

12. School of Psychology, Institute for Mental Health, University of Birmingham , Birmingham , UK

13. Early Intervention for Psychosis Services, Birmingham Women’s and Children’s NHS Foundation Trust , Birmingham , UK

14. Department of Psychiatry, University of California, San Diego , CA , USA

15. Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA , USA

16. Department of Psychology, Yale University , New Haven, CT , USA

17. IBM T.J. Watson Research Center , Yorktown Heights, NY , USA

18. Department of Psychiatry, University of Hong Kong , Pok Fu Lam , Hong Kong

19. Olin Neuropsychiatry Research Center, Hartford Hospital , Hartford, CT , USA

20. Discipline of Psychiatry, University of Adelaide , Adelaide, SA , Australia

21. Basil Hetzel Institute , Woodville, SA , Australia

22. General Psychiatry Service, Treatment and Early Intervention in Psychosis Program (TIPP–Lausanne), Lausanne University Hospital and University of Lausanne , Lausanne , Switzerland

23. Department of Psychiatry, Icahn School of Medicine at Mount Sinai , New York, NY , USA

24. Department of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell , Hempstead, NY , USA

25. Institute of Behavioral Science, Feinstein Institutes for Medical Research, Northwell Health , Manhasset, NY , USA

26. Centre for Neuropsychiatric Schizophrenia Research, CNSR Mental Health Centre, Glostrup , Copenhagen , Denmark

27. Department of Psychology and Neuroscience, Temple University , Philadelphia, PA , USA

28. Department of Psychosis Studies, King’s College London , London , UK

29. Department of Brain and Behavioral Sciences, University of Pavia , Pavia , Italy

30. Cambridgeshire and Peterborough NHS Foundation Trust , Cambridge , UK

31. Department of Psychiatry, University of Cambridge , Cambridge , UK

32. Department of Psychiatry, IMHAY, University of Chile , Santiago , Chile

33. Behavioral Health Services, PeaceHealth Medical Group , Eugene, OR , USA

34. Copenhagen Research Centre for Mental Health, Mental Health Copenhagen, University of Copenhagen , Denmark

35. Department of Psychology, University of Copenhagen , Copenhagen , Denmark

36. Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School , Boston, MA , USA

37. Department of Biostatistics, Harvard T.H. Chan School of Public Health and Harvard Medical School , Boston, MA , USA

38. Department of Psychiatry, Washington University School of Medicine , St. Louis, MO , USA

39. Department of Psychiatry, University of Pittsburgh School of Medicine , Pittsburgh, PA , USA

40. Department of Psychiatry, Faculty of Medicine and University Hospital Cologne, University of Cologne , Cologne , Germany

41. Department of Radiology, Brigham and Women’s Hospital , Boston, MA , USA

42. Department of Psychiatry, Beth Israel Deaconess Medical Center and Harvard Medical School , Boston, MA , USA

43. Department of Psychiatry, Chonnam National University Medical School , Gwangju , Korea

44. Mindlink, Gwangju Bukgu Mental Health Center , Gwangju , Korea

45. Department of Psychiatry and Psychotherapy, Ludwig Maximilian University of Munich , Munich , Germany

46. Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School , Boston, MA , USA

47. Department of Psychiatry, Seoul National University College of Medicine , Seoul , Korea

48. Department of Neuropsychiatry, Seoul National University Hospital , Seoul , Korea

49. Department of Psychiatry and Psychotherapy, Jena University Hospital , Jena , Germany

50. Veterans Affairs San Diego Health Care System , San Diego, CA , USA

51. Department of Psychiatry, Washington University Medical School , St. Louis, MO , USA

52. Northwell Health , Glen Oaks, NY , USA

53. Department of Psychiatry and Behavioral Sciences and Weill Institute for Neurosciences, University of California, San Francisco , San Francisco, CA , USA

54. Mental Health Service 116D, Veterans Affairs San Francisco Health Care System , San Francisco, CA , USA

55. Department of Psychology, Northwestern University , Evanston, IL , USA

56. Department of Clinical Medicine, University of Copenhagen , Copenhagen , Denmark

57. CAMEO, Early Intervention in Psychosis Service, Cambridgeshire and Peterborough NHS Foundation Trust , Cambridge , UK

58. Department of Medicine, Institute of Biomedical Research (IBSAL), Universidad de Salamanca , Salamanca , Spain

59. Department of Psychiatry, University of North Carolina at Chapel Hill , Chapel Hill, NC , USA

60. Prevention Science Institute, University of Oregon , Eugene, OR , USA

61. Department of Psychological Science, University of California, Irvine , Irvine, CA , USA

62. PEPP-Montreal, Douglas Research Centre , Montreal, Quebec , Canada

63. Department of Psychiatry, McGill University , Montreal, Quebec , Canada

64. Department of Psychology, University of Georgia , Athens, GA , USA

65. Birmingham Womens and Childrens, NHS Foundation Trust , Birmingham , UK

66. Department of Radiology, Massachusetts General Hospital and Harvard Medical School , Boston, MA , USA

67. Department of Psychosis, Institute of Mental Health , Singapore

68. Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine , Shanghai , China

69. Department of Psychology, Emory University , Atlanta, GA , USA

70. School of Psychology, University of Birmingham , Edgbaston , UK

71. Institute of Mental and Physical Health and Clinical Translation (IMPACT), Deakin University , Geelong, VIC , Australia

72. School of Health Sciences, University of Manchester , Manchester , UK

73. Youth Early Detection/Intervention in Psychosis Platform (Plateforme ERA), Service of Child and Adolescent Psychiatry, Department of Psychiatry, Lausanne University Hospital and The University of Lausanne , Lausanne , Switzerland

74. Department Psychiatry, Beaumont Hospital , Dublin 9 , Ireland

75. Department of Psychiatry, Royal College of Surgeons in Ireland , Dublin 2 , Ireland

76. School of Computing and Information Systems, The University of Melbourne , Parkville, VIC , Australia

77. Centre for Human Brain Health, School of Psychology, University of Birmingham , Birmingham , UK

78. Program for Specialized Treatment Early in Psychosis (STEP), CMHC , New Haven, CT , USA

79. Department of Psychology, Stanford University , Stanford, CA , USA

80. School of Psychology, University of New South Wales (UNSW) , Kensington, NSW , Australia

81. Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion Regulation, University of Groningen, University Medical Center,Groningen , Netherlands

82. Division of Digital Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School , Boston, MA , USA

83. John A. Paulson School of Engineering and Applied Sciences, Harvard University , Cambridge, MA , USA

84. Department of Psychiatry, Center for Psychiatric Neuroscience, Lausanne University Hospital and University of Lausanne (CHUV-UNIL) , Lausanne , Switzerland

85. Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience King’s College London , London , UK

86. Renaissance Computing Institute, University of North Carolina , Chapel Hill, NC , USA

87. Medical Informatics Fellowship, Veteran Affairs Boston Healthcare System , Boston, MA , USA

88. Food and Drug Administration , Silver Spring, MD , USA

89. Department of Psychiatry, Neurodevelopment & Psychosis Section, University of Pennsylvania , Philadelphia, PA , USA

90. IRCCS Mondino Foundation , Pavia , Italy

91. Department of Neurology and Psychiatry, Clínica Alemana—Universidad del Desarrollo , Santiago , Chile

92. Early Psychosis Detection and Clinical Intervention (EPIC) Lab, Department of Psychosis Studies, King’s College London , London , UK

93. Department of Public Mental Health, Central Institute of Mental Health, Heidelberg Univeristy , Mannheim , Germany

94. Neuroradiology Department, IRCCS Mondino Foundation , Pavia , Italy

95. Unidad de imágenes cuantitativas avanzadas, departamento de imágenes, clínica alemana, universidad del Desarrollo , Santiago , Chile

96. Facultad de ciencias para el cuidado de la salud, Universidad San Sebastián, Campus Los Leones , Santiago , Chile

Abstract

Abstract This article describes the rationale, aims, and methodology of the Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ). This is the largest international collaboration to date that will develop algorithms to predict trajectories and outcomes of individuals at clinical high risk (CHR) for psychosis and to advance the development and use of novel pharmacological interventions for CHR individuals. We present a description of the participating research networks and the data processing analysis and coordination center, their processes for data harmonization across 43 sites from 13 participating countries (recruitment across North America, Australia, Europe, Asia, and South America), data flow and quality assessment processes, data analyses, and the transfer of data to the National Institute of Mental Health (NIMH) Data Archive (NDA) for use by the research community. In an expected sample of approximately 2000 CHR individuals and 640 matched healthy controls, AMP SCZ will collect clinical, environmental, and cognitive data along with multimodal biomarkers, including neuroimaging, electrophysiology, fluid biospecimens, speech and facial expression samples, novel measures derived from digital health technologies including smartphone-based daily surveys, and passive sensing as well as actigraphy. The study will investigate a range of clinical outcomes over a 2-year period, including transition to psychosis, remission or persistence of CHR status, attenuated positive symptoms, persistent negative symptoms, mood and anxiety symptoms, and psychosocial functioning. The global reach of AMP SCZ and its harmonized innovative methods promise to catalyze the development of new treatments to address critical unmet clinical and public health needs in CHR individuals.

Publisher

Oxford University Press (OUP)

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