The Food and Drug Administration (FDA) has approved Lexapro (escitalopram) for the treatment of generalized anxiety disorder (GAD) in pediatric patients 7 years of age and older. Previously, the treatment had only been approved for adult patients.
Lexapro is a selective serotonin reuptake inhibitor (SSRI). The expanded pediatric approval was based on data from an 8-week, flexible-dose study (ClinicalTrials.gov Identifier: NCT03924323) that compared escitalopram (10mg and 20mg daily) to 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]). As for safety, the overall profile of adverse reactions in pediatric patients with GAD was similar to that seen in adult studies.
The prescribing information for Lexapro contains a Boxed Warning regarding an increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants. Patients should be monitored closely for clinical worsening and the emergence of suicidal thoughts and behaviors. The treatment is not approved for patients younger than 7 years old.
- Food and Drug Administration. letter. Accessed May 17, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021323Orig1s055,021365Orig1s039ltr.pdf.
- Package insert. AbbVie; 2023. Accessed May 17, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021323s055,021365s039lbl.pdf.