A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder

Phase 4 Completed 273 enrolled AbbVie

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a study in minors (7 to 17 years old) diagnosed with generalized anxiety disorder (GAD) and evaluated using standard questionnaires as having at least moderate severity of GAD. Participating minors will be assigned to receive either the study drug escitalopram or a pill without any drug in it called a placebo. The purpose of this research is to study the safety and effectiveness of escitalopram in minors with GAD.

Timeline

Start: 2019-05-30
Primary completion: 2021-09-20
Completion: 2021-09-20

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Escitalopram 10 mg/Day; p = 0.0281; least squares mean difference -1.42 (95% CI -2.69 to -0.15); mixed-effects model for repeated measure NCT03924323 ↗

paper Escitalopram was superior to placebo in reducing anxiety symptoms of GAD PMID 37074330 ↗

Publications

Strawn JR, Moldauer L, Hahn RD, Wise A, Bertzos K, Eisenberg B, Greenberg E, Liu C, Gopalkrishnan M, McVoy M, Knutson JA. A Multicenter Double-Blind, Placebo-Controlled Trial of Escitalopram in Children and Adolescents with Generalized Anxiety Disorder. J Child Adolesc Psychopharmacol. 2023 Apr;33(3):91-100. doi: 10.1089/cap.2023.0004.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Escitalopram	Small molecule	10 mg	Oral
Subject	Escitalopram	Small molecule	20 mg	Oral