Rationale and design for a pragmatic randomized trial to assess gene‐based prescribing for SSRIs in the treatment of depression

Autor: Lindsay J. Hines, Russell A. Wilke, Rachel Myers, Carol A. Mathews, Michelle Liu, Jordan F. Baye, Natasha Petry, Emily J. Cicali, Benjamin Q. Duong, Erica Elwood, Leslie Hulvershorn, Khoa Nguyen, Michelle Ramos, Azita Sadeghpour, R. Ryanne Wu, Lloyda Williamson, Kristin Wiisanen, Deepak Voora, Rajbir Singh, Kathryn V. Blake, James W. Murrough, Simona Volpi, Geoffrey S. Ginsburg, Carol R. Horowitz, Lori Orlando, Hrishikesh Chakraborty, Paul Dexter, Julie A. Johnson, Todd C. Skaar, Larisa H. Cavallari, Sara L. Van Driest, Josh F. Peterson, the IGNITE Pragmatic Trials Network
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Clinical and Translational Science, Vol 17, Iss 6, Pp n/a-n/a (2024)
Druh dokumentu: article
ISSN: 1752-8062
1752-8054
DOI: 10.1111/cts.13822
Popis: Abstract Specific selective serotonin reuptake inhibitors (SSRIs) metabolism is strongly influenced by two pharmacogenes, CYP2D6 and CYP2C19. However, the effectiveness of prospectively using pharmacogenetic variants to select or dose SSRIs for depression is uncertain in routine clinical practice. The objective of this prospective, multicenter, pragmatic randomized controlled trial is to determine the effectiveness of genotype‐guided selection and dosing of antidepressants on control of depression in participants who are 8 years or older with ≥3 months of depressive symptoms who require new or revised therapy. Those randomized to the intervention arm undergo pharmacogenetic testing at baseline and receive a pharmacy consult and/or automated clinical decision support intervention based on an actionable phenotype, while those randomized to the control arm have pharmacogenetic testing at the end of 6‐months. In both groups, depression and drug tolerability outcomes are assessed at baseline, 1 month, 3 months (primary), and 6 months. The primary end point is defined by change in Patient‐Reported Outcomes Measurement Information System (PROMIS) Depression score assessed at 3 months versus baseline. Secondary end points include change inpatient health questionnaire (PHQ‐8) measure of depression severity, remission rates defined by PROMIS score
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