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

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.

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UNC Libraries
Published
2024-10-18
DOI
https://doi.org/10.17615/rqtf-zj40
Primary Topic
Pharmaceutical studies and practices
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article
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article

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

Matcheri S. Keshavan, Samantha Aversa, Pamela Contreras, Phillip Wolff et al.
UNC Libraries
Pharmaceutical studies and practices
article

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

Matcheri S. Keshavan, Samantha Aversa, Pamela Contreras, Phillip Wolff, Anna Pichiecchio, Melanie Formica, Rocío Mayol-Troncoso, Sylvain Bouix, Zarina Bilgrami, Martina Maria Mensi, David Cotter, Celso Arango, Barbara A. Cornblatt, Alan Anticevic, John M. Kane, Mariam Omar, Lipeng Ning, Diana O. Perkins, Christopher J. Markiewicz, Ilaria Bonoldi, Nora Penzel, Jai L. Shah, Tina Gupta, Andrew Jin Soo Byun, Simon D’Alfonso, Nicholas Prunier, Holly Hamilton, Albert R. Powers, Godfrey D. Pearlson, Melanie Lafanechere, Carrie E. Bearden, Josh Mervis, Fred W. Sabb, Kerstin Langbein, Honey Kim, Yohannes Mebrahtu, Irena Kesselring, Jason Eric Schiffman, Danielle McLaughlin, Laura Adery, Sarah Whitson, M. Mallar Chakravarty, Johanna M. Jarcho, Gregory P. Strauss, Jijun Wang, Philippe Conus, Sage Rush, Raquel E. Gur, Alessia McGowan, Daniel H. Mathalon, Bernalyn Ruiz‐Yu, Marco Armando, Johanna Bayer, Munaza Ali, Vinod H. Srihari, Suheyla Cetin‐Karayumak, Anastasia Haidar, Swapna Verma, Gregory A. Light, Jessica Hartmann, Lana Kambeitz‐Ilankovic, John Blake Torous, Jun Soo Kwon, Mia Geljic, Justine Chen, Seon-Hwa Baek, Stephen James Wood, Avraham Reichenberg, Dominic Dwyer, Christian G. Kohler, Andrew David Thompson, Suzie Lavoie, Alejandro Maturana, René S. Kahn, Paris Alexandros Lalousis, Tashrif Billah, Matthew R. Broome, Habiballah Rahimi-Eichi, Melissa Kerr, Alyssa J. Bathery, Michael P. Harms, Andrés Estradé, Johanna T. W. Wigman, Scott Richard Clark, Clara Fonteneau, Covadonga M. Díaz‐Caneja, Shreyas Fadnavis, Merete Nordentoft, Martín Lepage, Bruce I. Turetsky, Yogesh Rathi, Robert J. Glynn, Clarice Lee, Jack Rogers, Márk Vangel, Isabelle Scott, Carla Gerber, David R. Roalf, Ofer Pasternak, Ricardo E. Carrión, Mathias Goncalves, Renato Borgatti, Yoonho Chung, Rachel A. Rabin, Kosha Ruparel, Liliana Galindo, Kevin Huynh, Beier Yao, Russell A. Poldrack, Jessica Spark, Christy Lai Ming Hui, Barnaby Nelson, Andrea M. Auther, Pablo A. Gaspar, Nicholas Cheng, G Santorelli, Jean Addington, Marija Krcmar, Cheryl M. Corcoran, Valentina Mantua, Jesús Pérez, Einat Liebenthal, Sarah Youn, John D. Cahill, Susan Ray, Caroline X. Gao, Umberto Provenzani, Rachel Upthegrove, Danielle N Pratt, Youngsun Cho, William S. Stone, Patrick D. McGorry, Carsten Langholm, Ruben C. Gur, Jenna Reinen, Sarah Kerins, Kathryn E. Lewandowski, Paolo Fusar‐Poli, Stefano Damiani, Jamie Zinberg, Gil D. Hoftman, Michaela Ennis, Stephanie Ming Yin Wong, Marek Kubicki, Beau‐Luke Colton, Yi Nam Suen, Brittany McQueen, Daniel Mamah, Zailyn Tamayo, Monica E. Calkins, Jashmina Shetty, Kate Buccilli, Kelly Allott, Anna Jo, Kyle S. Kinney, Sophie Tod, Pablo I. Polosecki, Rolando I Castillo-Passi, Michael Coleman, Tatiana Adasme, Alejandro Bruna, Vishnu P. Murty, Hok Pan Yuen, Scott W. Woods, Clark Jeffries, G. Paul Amminger, Justin T. Baker, Bjørn Hylsebeck Ebdrup, Eduardo Castro, Pierluigi Politi, Stefan Smesny, Kristin S. Cadenhead, Patricia Marcy, Victoria Rayner, Monica Done, Omar John, Mario Álvarez‐Jiménez, Christina Phassouliotis, Johanna Seitz‐Holland, Jie Lisa Ji, Alison Ruth Yung, Ann Ee Ching, Eirini Zoupou, Martha E. Shenton, Cassandra M. J. Wannan, Holly Carrington, Carmela Germano, Elissa Zavaglia, Kim Q., Daniel H. Wolf, Grace R. Jacobs, Francisco Zamorano, Alice Partridge, Joseph Kambeitz, Spero Nicholas, Vijay Anand Mittal, Inge Winter-van Rossum, Sebastián A. Corral, Carla Agurto, Louise Birkedal Glenthøj, Ameneh Asgari-Targhi, Tyrone D. Cannon, Leslie E. Horton, Jimmy Choi, Thomas J. Whitford, Ruth Getachew, Nikolaos Koutsouleris, Tina Kapur, Rebecca Beedham, Joshua Llerena, Elana Kotler, Lauren Addamo, Owen Borders, Brandon Asika Etuka, Priya Matnejl, Aissata Mavambu, Rebecca McIlhenny, Callum Snowball, Gabriel Turra-Fariña, Simone Veale, Kang Ik K. Cho, Sung‐Wan Kim, Eric Yu Hai Chen, Daniela Valle, Kate Reynolds, Nicholas Kim, Lisa Brown, Neal Morrell, Rachel Furlan, Alana Wickham, Ángela Núñez, Barbara C. Walsh, Guillermo Cecci, A McDonnell, Lauren M. Ellman, César Salinas, Agrima Srivastava, Erlend Lane, Chloe Clifford, Jasmine Raj, Manuel Reyes, Eric Lin, Larry D. Hendricks, Kelly Bates, Sonia Birch, Uzair Ahmed, Chris L. Porter
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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.

UNC Libraries
University of North Carolina at Chapel Hill (US)
U.S. Department of Health and Human Services, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, Biogen, Takeda Pharmaceuticals U.S.A., Sunovion, Neurocrine Biosciences, National Institute for Health and Care Research, Gedeon Richter, Ministerio de Ciencia e Innovación, Servier, H. Lundbeck A/S, National Institutes of Health, Medical Research Council, National Health and Medical Research Council, Instituto de Salud Carlos III, National Institute of Mental Health, Cilag
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