Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ): Rationale and Study Design of the Largest Global Prospective Cohort Study of Clinical High Risk for Psychosis
Cassandra Wannan, Barnaby Nelson, Jean Addington, Kelly Allott, Alan Anticevic, Celso Arango, Justin T. Baker, Carrie E. Bearden, Tashrif Billah, Sylvain Bouix, Matthew R. Broome, Kate Buccilli, Kristin S. Cadenhead, Monica E. Calkins, Tyrone D. Cannon, Guillermo Cecci, Eric Chen, Kang Ik K. Cho, Jimmy Choi, Scott R. Clark, Michael Coleman, Philippe Conus, Cheryl M. Corcoran, Barbara A. Cornblatt, Covadonga M. Díaz‐Caneja, Dominic Dwyer, Bjørn H. Ebdrup, Lauren M. Ellman, Paolo Fusar‐Poli, Liliana Galindo, Pablo A. Gaspar, Carla Gerber, Louise Birkedal Glenthøj, Robert J. Glynn, Michael P. Harms, Leslie E. Horton, René S. Kahn, Joseph Kambeitz, Lana Kambeitz‐Ilankovic, John M. Kane, Tina Kapur, Matcheri S. Keshavan, Sung‐Wan Kim, Nikolaos Koutsouleris, Marek Kubicki, Jun Soo Kwon, Kerstin Langbein, Kathryn E. Lewandowski, Gregory A. Light, Daniel Mamah, Patricia Marcy, Daniel H. Mathalon, Patrick D. McGorry, Vijay A. Mittal, Merete Nordentoft, Ángela Núñez, Ofer Pasternak, Godfrey D. Pearlson, Jesús Pérez, Diana O. Perkins, Albert R. Powers, David R. Roalf, Fred W. Sabb, Jason Schiffman, Jai Shah, Stefan Smesny, Jessica Spark, William S. Stone, Gregory P. Strauss, Zailyn Tamayo, John Torous, Rachel Upthegrove, Márk Vangel, Swapna Verma, Jijun Wang, Inge Winter-van Rossum, Daniel H. Wolf, Phillip Wolff, Stephen J. Wood, Alison R. Yung, Carla Agurto, Mario Álvarez‐Jiménez, G. Paul Amminger, Marco Armando, Ameneh Asgari-Targhi, John D. Cahill, Ricardo E. Carrión, Eduardo Castro, Suheyla Cetin‐Karayumak, M. Mallar Chakravarty, Youngsun Cho, David Cotter, Simon D’Alfonso, Michaela Ennis, Shreyas Fadnavis, Clara Fonteneau, Caroline X. Gao, Tina Gupta, Raquel E. Gur, Ruben C. Gur
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.