The U.S. Food and Drug Administration (FDA) has approved escitalopram for the treatment of generalized anxiety disorder (GAD) in pediatric patients 7 years of age and older.
The expanded pediatric approval was based on data from an 8-week, flexible-dose study that compared escitalopram, 10mg and 20mg daily, versus placebo in outpatients 7 to 17 years of age who met DSM-V criteria for GAD. The primary endpoint of the trial was the change in Pediatric Anxiety Rating Scale (PARS) severity score from baseline to week 8. The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms; PARS severity scores for GAD range from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Findings showed a statistically significant treatment difference with escitalopram compared with placebo on the PARS severity score for GAD (least squares mean difference, -1.42 [95% CI, -2.69, -0.15]). The overall profile of adverse reactions in pediatric patients with GAD was similar to that seen in adult studies. Escitalopram is now one of only two medications approved by the FDA for the treatment of anxiety in children and adolescents and the first SSRI to receive this indication. The selective serotonin/norepinephrine reuptake inhibitor (SNRI), duloxetine, was approved by the FDA in October 2014 for children aged 7 to 17 years for generalized anxiety disorders.
>> Package insert. AbbVie; 2023.
Strawn JR et al. J Child Adolesc Psychopharmacol. 2023;33(3):91-100. Abstract
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