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Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ): Rationale and Study Design of the Largest Global Prospective Cohort Study of Clinical High Risk for Psychosis
Schizophrenia Bulletin ( IF 6.6 ) Pub Date : 2024-03-07 , DOI: 10.1093/schbul/sbae011
Cassandra M J Wannan 1, 2 , Barnaby Nelson 1, 2 , Jean Addington 3 , Kelly Allott 1, 2 , Alan Anticevic 4, 5 , Celso Arango 6 , Justin T Baker 7 , Carrie E Bearden 8, 9 , Tashrif Billah 10 , Sylvain Bouix 11 , Matthew R Broome 12, 13 , Kate Buccilli 1, 2 , Kristin S Cadenhead 14 , Monica E Calkins 15 , Tyrone D Cannon 4, 16 , Guillermo Cecci 17 , Eric Yu Hai Chen 18 , Kang Ik K Cho 9 , Jimmy Choi 19 , Scott R Clark 20, 21 , Michael J Coleman 9 , Philippe Conus 22 , Cheryl M Corcoran 23 , Barbara A Cornblatt 24, 25 , Covadonga M Diaz-Caneja 6 , Dominic Dwyer 1, 2 , Bjørn H Ebdrup 26 , Lauren M Ellman 27 , Paolo Fusar-Poli 28, 29 , Liliana Galindo 30, 31 , Pablo A Gaspar 32 , Carla Gerber 33 , Louise Birkedal Glenthøj 34, 35 , Robert Glynn 36, 37 , Michael P Harms 38 , Leslie E Horton 39 , René S Kahn 23 , Joseph Kambeitz 40 , Lana Kambeitz-Ilankovic 40 , John M Kane 24, 25 , Tina Kapur 41 , Matcheri S Keshavan 42 , Sung-Wan Kim 43, 44 , Nikolaos Koutsouleris 45 , Marek Kubicki 9, 46 , Jun Soo Kwon 47, 48 , Kerstin Langbein 49 , Kathryn E Lewandowski 7 , Gregory A Light 14, 50 , Daniel Mamah 51 , Patricia J Marcy 52 , Daniel H Mathalon 53, 54 , Patrick D McGorry 1, 2 , Vijay A Mittal 55 , Merete Nordentoft 34, 56 , Angela Nunez 4, 5 , Ofer Pasternak 9, 46 , Godfrey D Pearlson 4, 19 , Jesus Perez 57, 58 , Diana O Perkins 59 , Albert R Powers 4, 5 , David R Roalf 15 , Fred W Sabb 60 , Jason Schiffman 61 , Jai L Shah 62, 63 , Stefan Smesny 49 , Jessica Spark 1, 2 , William S Stone 42 , Gregory P Strauss 64 , Zailyn Tamayo 4, 5 , John Torous 43 , Rachel Upthegrove 11, 65 , Mark Vangel 66 , Swapna Verma 67 , Jijun Wang 68 , Inge Winter-van Rossum 25 , Daniel H Wolf 15 , Phillip Wolff 69 , Stephen J Wood 1, 2, 70 , Alison R Yung 71, 72 , Carla Agurto 17 , Mario Alvarez-Jimenez 1, 2 , Paul Amminger 1, 2 , Marco Armando 73 , Ameneh Asgari-Targhi 41 , John Cahill 4, 5 , Ricardo E Carrión 24, 25 , Eduardo Castro 17 , Suheyla Cetin-Karayumak 9 , M Mallar Chakravarty 63 , Youngsun T Cho 4, 5 , David Cotter 74, 75 , Simon D’Alfonso 76 , Michaela Ennis 7 , Shreyas Fadnavis 9 , Clara Fonteneau 4, 5 , Caroline Gao 1, 2 , Tina Gupta 39 , Raquel E Gur 15 , Ruben C Gur 15 , Holly K Hamilton 10 , Gil D Hoftman 8, 9 , Grace R Jacobs 10 , Johanna Jarcho 27 , Jie Lisa Ji 4, 5 , Christian G Kohler 15 , Paris Alexandros Lalousis 12, 77 , Suzie Lavoie 1, 2 , Martin Lepage 63 , Einat Liebenthal 78 , Josh Mervis 27 , Vishnu Murty 27 , Spero C Nicholas 51 , Lipeng Ning 9, 41 , Nora Penzel 9 , Russell Poldrack 79 , Pablo Polosecki 17 , Danielle N Pratt 55 , Rachel Rabin 62 , Habiballah Rahimi Eichi 7 , Yogesh Rathi 10, 41 , Avraham Reichenberg 23 , Jenna Reinen 17 , Jack Rogers 77 , Bernalyn Ruiz-Yu 8 , Isabelle Scott 1, 2 , Johanna Seitz-Holland 10 , Vinod H Srihari 4, 78 , Agrima Srivastava 23 , Andrew Thompson 1, 2 , Bruce I Turetsky 15 , Barbara C Walsh 4, 5 , Thomas Whitford 2, 80 , Johanna T W Wigman 81 , Beier Yao 7 , Hok Pan Yuen 1, 2 , Uzair Ahmed 2 , Andrew (Jin Soo) Byun 82, 83 , Yoonho Chung 7 , Kim Do 84, 85 , Larry Hendricks 1, 2 , Kevin Huynh 1, 2 , Clark Jeffries 86 , Erlend Lane 42 , Carsten Langholm 42 , Eric Lin 7, 87, 88 , Valentina Mantua 89 , Gennarina Santorelli 43 , Kosha Ruparel 16 , Eirini Zoupou 16 , Tatiana Adasme 32 , Lauren Addamo 1, 2 , Laura Adery 8, 9 , Munaza Ali 4, 5 , Andrea Auther 24 , Samantha Aversa 62 , Seon-Hwa Baek 43, 44 , Kelly Bates 55 , Alyssa Bathery 89 , Johanna M M Bayer 1, 2 , Rebecca Beedham 1, 2 , Zarina Bilgrami 69 , Sonia Birch 1, 2 , Ilaria Bonoldi 28, 29 , Owen Borders 10 , Renato Borgatti 29, 90 , Lisa Brown 41 , Alejandro Bruna 32 , Holly Carrington 10 , Rolando I Castillo-Passi 32, 91 , Justine Chen 10 , Nicholas Cheng 1, 2 , Ann Ee Ching 1, 2 , Chloe Clifford 12 , Beau-Luke Colton 1, 2 , Pamela Contreras 32 , Sebastián Corral 32 , Stefano Damiani 29 , Monica Done 8, 9 , Andrés Estradé 92 , Brandon Asika Etuka 4 , Melanie Formica 1, 2 , Rachel Furlan 27 , Mia Geljic 1, 2 , Carmela Germano 1, 2 , Ruth Getachew 1, 2 , Mathias Goncalves 79 , Anastasia Haidar 10 , Jessica Hartmann 93 , Anna Jo 43 , Omar John 10 , Sarah Kerins 92 , Melissa Kerr 1, 2 , Irena Kesselring 89 , Honey Kim 43 , Nicholas Kim 10 , Kyle Kinney 27 , Marija Krcmar 1, 2 , Elana Kotler 10 , Melanie Lafanechere 70, 77 , Clarice Lee 1, 2 , Joshua Llerena 1, 2 , Christopher Markiewicz 79 , Priya Matnejl 52 , Alejandro Maturana 32 , Aissata Mavambu 12 , Rocío Mayol-Troncoso 32 , Amelia McDonnell 27 , Alessia McGowan 23 , Danielle McLaughlin 52 , Rebecca McIlhenny 39 , Brittany McQueen 1, 2 , Yohannes Mebrahtu 1, 2 , Martina Mensi 29, 90 , Christy Lai Ming Hui 18 , Yi Nam Suen 18 , Stephanie Ming Yin Wong 18 , Neal Morrell 1, 2 , Mariam Omar 1, 2 , Alice Partridge 1, 2 , Christina Phassouliotis 1, 2 , Anna Pichiecchio 29, 94 , Pierluigi Politi 29 , Christian Porter 39 , Umberto Provenzani 29 , Nicholas Prunier 10 , Jasmine Raj 55 , Susan Ray 52 , Victoria Rayner 1, 2 , Manuel Reyes 32, 91 , Kate Reynolds 1, 2 , Sage Rush 89 , Cesar Salinas 32 , Jashmina Shetty 1, 2 , Callum Snowball 1, 2 , Sophie Tod 1, 2 , Gabriel Turra-Fariña 32 , Daniela Valle 32 , Simone Veale 10 , Sarah Whitson 1, 2 , Alana Wickham 10 , Sarah Youn 1, 2 , Francisco Zamorano 95, 96 , Elissa Zavaglia 62 , Jamie Zinberg 8, 9 , Scott W Woods 4, 5 , Martha E Shenton 10, 41, 46
Affiliation  

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.

中文翻译:

Acceleating Medicines Partnership® 精神分裂症 (AMP® SCZ):全球最大的精神病临床高风险前瞻性队列研究的基本原理和研究设计

本文介绍了 Accelerated Medicines Partnership® 精神分裂症 (AMP® SCZ) 的基本原理、目标和方法。这是迄今为止规模最大的国际合作,将开发算法来预测精神病临床高风险 (CHR) 个体的轨迹和结果,并推动针对 CHR 个体的新型药物干预措施的开发和使用。我们介绍了参与的研究网络以及数据处理分析和协调中心、来自 13 个参与国家的 43 个站点的数据协调流程(横跨北美、澳大利亚、欧洲、亚洲和南美的招聘)、数据流和质量评估流程、数据分析以及将数据传输到国家心理健康研究所 (NIMH) 数据档案 (NDA) 供研究界使用。在大约 2000 名 CHR 个体和 640 名匹配的健康对照的预期样本中,AMP SCZ 将收集临床、环境和认知数据以及多模式生物标志物,包括神经影像、电生理学、液体生物样本、言语和面部表情样本、源自数字的新测量方法健康技术,包括基于智能手机的日常调查、被动传感以及体动记录仪。该研究将调查两年内的一系列临床结果,包括向精神病的转变、CHR状态的缓解或持续、阳性症状减弱、阴性症状持续、情绪和焦虑症状以及心理社会功能。AMP SCZ 的全球影响力及其协调一致的创新方法有望促进新疗法的开发,以满足 CHR 个体未满足的关键临床和公共卫生需求。
更新日期:2024-03-07
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