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

Jean Addington; Lu Liu; Amy Braun; Andrea Auther; Monica E Calkins; Barbara A Cornblatt; Cheryl M Corcoran; Paolo Fusar-Poli; Melissa J Kerr; Catalina V Mourgues-Codern; Angela R Nunez; Dominic Oliver; Gregory P Strauss; Barbara C Walsh; Luis K Alameda; Celso Arango; Nicholas J K Breitborde; Matthew R Broome; Kristin S Cadenhead; Ricardo E Carrion; Eric Yu Hai Chen; Jimmy Choi; Michael J Coleman; Philippe Conus; Covadonga M Diaz-Caneja; Dominic Dwyer; Lauren M Ellman; Masoomeh Faghankhani; Pablo A Gaspar; Carla Gerber; Louise Birkedal Glenthøj; Leslie E Horton; Christy Hui; Grace R Jacobs; Joseph Kambeitz; Lana Kambeitz-Ilankovic; Matcheri S Keshavan; Sung-Wan Kim; Nikolaos Koutsouleris; Jun Soo Kwon; Kerstin Langbein; Kathryn E Lewandowski; Daniel Mamah; Patricia J Marcy; Daniel H Mathalon; Vijay A Mittal; Merete Nordentoft; Godfrey D Pearlson; Inge Winter-van Rossum; Rene S Kahn

doi:10.1038/s41537-025-00556-7

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

Jean Addington^*, Lu Liu, Amy Braun, Andrea Auther, Monica E Calkins, Barbara A Cornblatt, Cheryl M Corcoran, Paolo Fusar-Poli, Melissa J Kerr, Catalina V Mourgues-Codern, Angela R Nunez, Dominic Oliver, Gregory P Strauss, Barbara C Walsh, Luis K Alameda, Celso Arango, Nicholas J K Breitborde, Matthew R Broome, Kristin S Cadenhead, Ricardo E CarrionEric Yu Hai Chen, Jimmy Choi, Michael J Coleman, Philippe Conus, Covadonga M Diaz-Caneja, Dominic Dwyer, Lauren M Ellman, Masoomeh Faghankhani, Pablo A Gaspar, Carla Gerber, Louise Birkedal Glenthøj, Leslie E Horton, Christy Hui, Grace R Jacobs, Joseph Kambeitz, Lana Kambeitz-Ilankovic, Matcheri S Keshavan, Sung-Wan Kim, Nikolaos Koutsouleris, Jun Soo Kwon, Kerstin Langbein, Kathryn E Lewandowski, Daniel Mamah, Patricia J Marcy, Daniel H Mathalon, Vijay A Mittal, Merete Nordentoft, Godfrey D Pearlson, Inge Winter-van Rossum, Rene S Kahn,

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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 .

Original language	English
Article number	54
Journal	Schizophrenia
Volume	11
Issue number	1
DOIs	https://doi.org/10.1038/s41537-025-00556-7
Publication status	Published - 3 Apr 2025
Externally published	Yes

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Addington, J., Liu, L., Braun, A., Auther, A., Calkins, M. E., Cornblatt, B. A., Corcoran, C. M., Fusar-Poli, P., Kerr, M. J., Mourgues-Codern, C. V., Nunez, A. R., Oliver, D., Strauss, G. P., Walsh, B. C., Alameda, L. K., Arango, C., Breitborde, N. J. K., Broome, M. R., Cadenhead, K. S. (2025). Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program. Schizophrenia, 11(1), Article 54. https://doi.org/10.1038/s41537-025-00556-7

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title = "Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership{\textregistered} Schizophrenia Program",

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 {\textregistered} Schizophrenia (AMP {\textregistered}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 . ",

author = "Jean Addington and Lu Liu and Amy Braun and Andrea Auther and Calkins, {Monica E} and Cornblatt, {Barbara A} and Corcoran, {Cheryl M} and Paolo Fusar-Poli and Kerr, {Melissa J} and Mourgues-Codern, {Catalina V} and Nunez, {Angela R} and Dominic Oliver and Strauss, {Gregory P} and Walsh, {Barbara C} and Alameda, {Luis K} and Celso Arango and Breitborde, {Nicholas J K} and Broome, {Matthew R} and Cadenhead, {Kristin S} and Carrion, {Ricardo E} and Chen, {Eric Yu Hai} and Jimmy Choi and Coleman, {Michael J} and Philippe Conus and Diaz-Caneja, {Covadonga M} and Dominic Dwyer and Ellman, {Lauren M} and Masoomeh Faghankhani and Gaspar, {Pablo A} and Carla Gerber and Glenth{\o}j, {Louise Birkedal} and Horton, {Leslie E} and Christy Hui and Jacobs, {Grace R} and Joseph Kambeitz and Lana Kambeitz-Ilankovic and Keshavan, {Matcheri S} and Sung-Wan Kim and Nikolaos Koutsouleris and Kwon, {Jun Soo} and Kerstin Langbein and Lewandowski, {Kathryn E} and Daniel Mamah and Marcy, {Patricia J} and Mathalon, {Daniel H} and Mittal, {Vijay A} and Merete Nordentoft and Pearlson, {Godfrey D} and Rossum, {Inge Winter-van} and Kahn, {Rene S}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2025.",

year = "2025",

month = apr,

day = "3",

doi = "10.1038/s41537-025-00556-7",

language = "English",

volume = "11",

journal = "Schizophrenia",

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Addington, J, Liu, L, Braun, A, Auther, A, Calkins, ME, Cornblatt, BA, Corcoran, CM, Fusar-Poli, P, Kerr, MJ, Mourgues-Codern, CV, Nunez, AR, Oliver, D, Strauss, GP, Walsh, BC, Alameda, LK, Arango, C, Breitborde, NJK, Broome, MR, Cadenhead, KS, Carrion, RE, Chen, EYH, Choi, J, Coleman, MJ, Conus, P, Diaz-Caneja, CM, Dwyer, D, Ellman, LM, Faghankhani, M, Gaspar, PA, Gerber, C, Glenthøj, LB, Horton, LE, Hui, C, Jacobs, GR, Kambeitz, J, Kambeitz-Ilankovic, L, Keshavan, MS, Kim, S-W, Koutsouleris, N, Kwon, JS, Langbein, K, Lewandowski, KE, Mamah, D, Marcy, PJ, Mathalon, DH, Mittal, VA, Nordentoft, M, Pearlson, GD, Rossum, IW, Kahn, RS 2025, 'Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program', Schizophrenia, vol. 11, no. 1, 54. https://doi.org/10.1038/s41537-025-00556-7

TY - JOUR

T1 - Sample ascertainment and clinical outcome measures in the Accelerating Medicines Partnership® Schizophrenia Program

AU - Addington, Jean

AU - Liu, Lu

AU - Braun, Amy

AU - Auther, Andrea

AU - Calkins, Monica E

AU - Cornblatt, Barbara A

AU - Corcoran, Cheryl M

AU - Fusar-Poli, Paolo

AU - Kerr, Melissa J

AU - Mourgues-Codern, Catalina V

AU - Nunez, Angela R

AU - Oliver, Dominic

AU - Strauss, Gregory P

AU - Walsh, Barbara C

AU - Alameda, Luis K

AU - Arango, Celso

AU - Breitborde, Nicholas J K

AU - Broome, Matthew R

AU - Cadenhead, Kristin S

AU - Carrion, Ricardo E

AU - Chen, Eric Yu Hai

AU - Choi, Jimmy

AU - Coleman, Michael J

AU - Conus, Philippe

AU - Diaz-Caneja, Covadonga M

AU - Dwyer, Dominic

AU - Ellman, Lauren M

AU - Faghankhani, Masoomeh

AU - Gaspar, Pablo A

AU - Gerber, Carla

AU - Glenthøj, Louise Birkedal

AU - Horton, Leslie E

AU - Hui, Christy

AU - Jacobs, Grace R

AU - Kambeitz, Joseph

AU - Kambeitz-Ilankovic, Lana

AU - Keshavan, Matcheri S

AU - Kim, Sung-Wan

AU - Koutsouleris, Nikolaos

AU - Kwon, Jun Soo

AU - Langbein, Kerstin

AU - Lewandowski, Kathryn E

AU - Mamah, Daniel

AU - Marcy, Patricia J

AU - Mathalon, Daniel H

AU - Mittal, Vijay A

AU - Nordentoft, Merete

AU - Pearlson, Godfrey D

AU - Rossum, Inge Winter-van

AU - Kahn, Rene S

PY - 2025/4/3

Y1 - 2025/4/3

N2 - 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 .

AB - 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 .

U2 - 10.1038/s41537-025-00556-7

DO - 10.1038/s41537-025-00556-7

M3 - Article

C2 - 40180953

SN - 2754-6993

VL - 11

JO - Schizophrenia

JF - Schizophrenia

IS - 1

M1 - 54

ER -

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

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