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Effects of Long-Term Sertraline Use on Pediatric Growth and Development: The Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES).

Publication ,  Journal Article
Kolitsopoulos, F; Ramaker, S; Compton, SN; Broderick, S; Orazem, J; Bao, W; Lokhnygina, Y; Marschall, K; Chappell, P
Published in: J Child Adolesc Psychopharmacol
February 2023

Objective: To describe the results of the Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES) outcome measures of cognitive, emotional, and physical development following long-term treatment with sertraline (for up to 3 years) in children and adolescents aged 6-16 years. Methods: SPRITES was a long-term, multicenter, open-label, prospective observational study designed to compare physical and psychological development in pediatric patients exposed to sertraline (with or without psychotherapy) or psychotherapy alone in usual care settings. Data were summarized descriptively, and outcomes were evaluated using a marginal structural model. Results: Between April 2012 and September 2020, 941 patients across 44 U.S. sites participated in the study. At baseline, 695 participants were exposed to sertraline (physician prescribed) with or without psychotherapy, and 245 participants were exposed to psychotherapy alone. Of these, 432 participants (46.0%) completed the full 3-year study follow-up. No significant changes across time were found in standardized height, BRIEF (Behavior Rating Inventory of Executive Function), Trails B, and Tanner stage based on cumulative sertraline exposure or exposure since the last visit. Change in mean standardized weight across time was positively associated with both cumulative sertraline exposure (p = 0.02) and exposure since the last visit (p = 0.029). The mean changes from baseline across time in standardized weight were standard deviations of 0.02, 0.03, 0.16, and 0.17 at months 3, 6, 30, and 36, respectively. However, this finding was not observed in the mean change across time in standardized body mass index, which was not statistically significant. Conclusions: Results are consistent with normal development. Although a statistically significant finding for standardized weight was observed in comparative analyses, the magnitude of the change is small and observed at higher doses of sertraline only. No other significant differences were observed between the "sertraline" group and the "no pharmacological therapy" group on other primary outcome measures. ClinicalTrials.gov identifier: NCT01302080.

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Published In

J Child Adolesc Psychopharmacol

DOI

EISSN

1557-8992

Publication Date

February 2023

Volume

33

Issue

1

Start / End Page

2 / 13

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Sertraline
  • Selective Serotonin Reuptake Inhibitors
  • Registries
  • Psychotherapy
  • Humans
  • Developmental & Child Psychology
  • Child
  • Adolescent
  • 3214 Pharmacology and pharmaceutical sciences
 

Citation

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Kolitsopoulos, F., Ramaker, S., Compton, S. N., Broderick, S., Orazem, J., Bao, W., … Chappell, P. (2023). Effects of Long-Term Sertraline Use on Pediatric Growth and Development: The Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES). J Child Adolesc Psychopharmacol, 33(1), 2–13. https://doi.org/10.1089/cap.2022.0048
Kolitsopoulos, Francesca, Sara Ramaker, Scott N. Compton, Samuel Broderick, John Orazem, Weihang Bao, Yuliya Lokhnygina, Kristina Marschall, and Phillip Chappell. “Effects of Long-Term Sertraline Use on Pediatric Growth and Development: The Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES).J Child Adolesc Psychopharmacol 33, no. 1 (February 2023): 2–13. https://doi.org/10.1089/cap.2022.0048.
Kolitsopoulos F, Ramaker S, Compton SN, Broderick S, Orazem J, Bao W, et al. Effects of Long-Term Sertraline Use on Pediatric Growth and Development: The Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES). J Child Adolesc Psychopharmacol. 2023 Feb;33(1):2–13.
Kolitsopoulos, Francesca, et al. “Effects of Long-Term Sertraline Use on Pediatric Growth and Development: The Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES).J Child Adolesc Psychopharmacol, vol. 33, no. 1, Feb. 2023, pp. 2–13. Pubmed, doi:10.1089/cap.2022.0048.
Kolitsopoulos F, Ramaker S, Compton SN, Broderick S, Orazem J, Bao W, Lokhnygina Y, Marschall K, Chappell P. Effects of Long-Term Sertraline Use on Pediatric Growth and Development: The Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES). J Child Adolesc Psychopharmacol. 2023 Feb;33(1):2–13.
Journal cover image

Published In

J Child Adolesc Psychopharmacol

DOI

EISSN

1557-8992

Publication Date

February 2023

Volume

33

Issue

1

Start / End Page

2 / 13

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Sertraline
  • Selective Serotonin Reuptake Inhibitors
  • Registries
  • Psychotherapy
  • Humans
  • Developmental & Child Psychology
  • Child
  • Adolescent
  • 3214 Pharmacology and pharmaceutical sciences