Pharmacogenetically Guided Escitalopram Treatment for Pediatric Anxiety Disorders: Protocol for a Double-Blind Randomized Trial

Current pharmacologic treatments for pediatric anxiety disorders (e.g., selective serotonin reuptake inhibitors (SSRIs)) frequently use “one size fits all” dosing strategies based on average responses in clinical trials. However, for some SSRIs, including escitalopram, variation in CYP2C19 activity...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Jeffrey R. Strawn, Ethan A. Poweleit, Jeffrey A. Mills, Heidi K. Schroeder, Zoe A. Neptune, Ashley M. Specht, Jenni E. Farrow, Xue Zhang, Lisa J. Martin, Laura B. Ramsey
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	selective serotonin reuptake inhibitor (SSRI) anxiety disorders generalized anxiety disorder (GAD) pharmacogenetic CYP2C19 pharmacokinetic Medicine R
Acceso en línea:	https://doaj.org/article/ffc9f63cbda640d6b0e82fab50b6edf4
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:ffc9f63cbda640d6b0e82fab50b6edf4
record_format	dspace
spelling	oai:doaj.org-article:ffc9f63cbda640d6b0e82fab50b6edf42021-11-25T18:07:53ZPharmacogenetically Guided Escitalopram Treatment for Pediatric Anxiety Disorders: Protocol for a Double-Blind Randomized Trial10.3390/jpm111111882075-4426https://doaj.org/article/ffc9f63cbda640d6b0e82fab50b6edf42021-11-01T00:00:00Zhttps://www.mdpi.com/2075-4426/11/11/1188https://doaj.org/toc/2075-4426Current pharmacologic treatments for pediatric anxiety disorders (e.g., selective serotonin reuptake inhibitors (SSRIs)) frequently use “one size fits all” dosing strategies based on average responses in clinical trials. However, for some SSRIs, including escitalopram, variation in CYP2C19 activity produces substantial variation in medication exposure (i.e., blood medication concentrations). This raises an important question: would refining current SSRI dosing strategies based on CYP2C19 phenotypes increase response and reduce side effect burden? To answer this question, we designed a randomized, double-blind trial of adolescents 12–17 years of age with generalized, separation, and/or social anxiety disorders (N = 132). Patients are randomized (1:1) to standard escitalopram dosing or dosing based on validated CYP2C19 phenotypes for escitalopram metabolism. Using this approach, we will determine whether pharmacogenetically-guided treatment—compared to standard dosing—produces faster and greater reduction in anxiety symptoms (i.e., response) and improves tolerability (e.g., decreased risk of treatment-related activation and weight gain). Secondarily, we will examine pharmacodynamic variants associated with treatment outcomes, thus enhancing clinicians’ ability to predict response and tolerability. Ultimately, developing a strategy to optimize dosing for individual patients could accelerate response while decreasing side effects—an immediate benefit to patients and their families. ClinicalTrials.gov Identifier: NCT04623099.Jeffrey R. StrawnEthan A. PoweleitJeffrey A. MillsHeidi K. SchroederZoe A. NeptuneAshley M. SpechtJenni E. FarrowXue ZhangLisa J. MartinLaura B. RamseyMDPI AGarticleselective serotonin reuptake inhibitor (SSRI)anxiety disordersgeneralized anxiety disorder (GAD)pharmacogeneticCYP2C19pharmacokineticMedicineRENJournal of Personalized Medicine, Vol 11, Iss 1188, p 1188 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	selective serotonin reuptake inhibitor (SSRI) anxiety disorders generalized anxiety disorder (GAD) pharmacogenetic CYP2C19 pharmacokinetic Medicine R
spellingShingle	selective serotonin reuptake inhibitor (SSRI) anxiety disorders generalized anxiety disorder (GAD) pharmacogenetic CYP2C19 pharmacokinetic Medicine R Jeffrey R. Strawn Ethan A. Poweleit Jeffrey A. Mills Heidi K. Schroeder Zoe A. Neptune Ashley M. Specht Jenni E. Farrow Xue Zhang Lisa J. Martin Laura B. Ramsey Pharmacogenetically Guided Escitalopram Treatment for Pediatric Anxiety Disorders: Protocol for a Double-Blind Randomized Trial
description	Current pharmacologic treatments for pediatric anxiety disorders (e.g., selective serotonin reuptake inhibitors (SSRIs)) frequently use “one size fits all” dosing strategies based on average responses in clinical trials. However, for some SSRIs, including escitalopram, variation in CYP2C19 activity produces substantial variation in medication exposure (i.e., blood medication concentrations). This raises an important question: would refining current SSRI dosing strategies based on CYP2C19 phenotypes increase response and reduce side effect burden? To answer this question, we designed a randomized, double-blind trial of adolescents 12–17 years of age with generalized, separation, and/or social anxiety disorders (N = 132). Patients are randomized (1:1) to standard escitalopram dosing or dosing based on validated CYP2C19 phenotypes for escitalopram metabolism. Using this approach, we will determine whether pharmacogenetically-guided treatment—compared to standard dosing—produces faster and greater reduction in anxiety symptoms (i.e., response) and improves tolerability (e.g., decreased risk of treatment-related activation and weight gain). Secondarily, we will examine pharmacodynamic variants associated with treatment outcomes, thus enhancing clinicians’ ability to predict response and tolerability. Ultimately, developing a strategy to optimize dosing for individual patients could accelerate response while decreasing side effects—an immediate benefit to patients and their families. ClinicalTrials.gov Identifier: NCT04623099.
format	article
author	Jeffrey R. Strawn Ethan A. Poweleit Jeffrey A. Mills Heidi K. Schroeder Zoe A. Neptune Ashley M. Specht Jenni E. Farrow Xue Zhang Lisa J. Martin Laura B. Ramsey
author_facet	Jeffrey R. Strawn Ethan A. Poweleit Jeffrey A. Mills Heidi K. Schroeder Zoe A. Neptune Ashley M. Specht Jenni E. Farrow Xue Zhang Lisa J. Martin Laura B. Ramsey
author_sort	Jeffrey R. Strawn
title	Pharmacogenetically Guided Escitalopram Treatment for Pediatric Anxiety Disorders: Protocol for a Double-Blind Randomized Trial
title_short	Pharmacogenetically Guided Escitalopram Treatment for Pediatric Anxiety Disorders: Protocol for a Double-Blind Randomized Trial
title_full	Pharmacogenetically Guided Escitalopram Treatment for Pediatric Anxiety Disorders: Protocol for a Double-Blind Randomized Trial
title_fullStr	Pharmacogenetically Guided Escitalopram Treatment for Pediatric Anxiety Disorders: Protocol for a Double-Blind Randomized Trial
title_full_unstemmed	Pharmacogenetically Guided Escitalopram Treatment for Pediatric Anxiety Disorders: Protocol for a Double-Blind Randomized Trial
title_sort	pharmacogenetically guided escitalopram treatment for pediatric anxiety disorders: protocol for a double-blind randomized trial
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/ffc9f63cbda640d6b0e82fab50b6edf4
work_keys_str_mv	AT jeffreyrstrawn pharmacogeneticallyguidedescitalopramtreatmentforpediatricanxietydisordersprotocolforadoubleblindrandomizedtrial AT ethanapoweleit pharmacogeneticallyguidedescitalopramtreatmentforpediatricanxietydisordersprotocolforadoubleblindrandomizedtrial AT jeffreyamills pharmacogeneticallyguidedescitalopramtreatmentforpediatricanxietydisordersprotocolforadoubleblindrandomizedtrial AT heidikschroeder pharmacogeneticallyguidedescitalopramtreatmentforpediatricanxietydisordersprotocolforadoubleblindrandomizedtrial AT zoeaneptune pharmacogeneticallyguidedescitalopramtreatmentforpediatricanxietydisordersprotocolforadoubleblindrandomizedtrial AT ashleymspecht pharmacogeneticallyguidedescitalopramtreatmentforpediatricanxietydisordersprotocolforadoubleblindrandomizedtrial AT jenniefarrow pharmacogeneticallyguidedescitalopramtreatmentforpediatricanxietydisordersprotocolforadoubleblindrandomizedtrial AT xuezhang pharmacogeneticallyguidedescitalopramtreatmentforpediatricanxietydisordersprotocolforadoubleblindrandomizedtrial AT lisajmartin pharmacogeneticallyguidedescitalopramtreatmentforpediatricanxietydisordersprotocolforadoubleblindrandomizedtrial AT laurabramsey pharmacogeneticallyguidedescitalopramtreatmentforpediatricanxietydisordersprotocolforadoubleblindrandomizedtrial
_version_	1718411599246524416

Pharmacogenetically Guided Escitalopram Treatment for Pediatric Anxiety Disorders: Protocol for a Double-Blind Randomized Trial

Ejemplares similares