NCT03924323

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

A Randomized, Multicenter, Double-Blind, Flexibly-dosed, Efficacy and Safety Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anxiety Disorders,Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Escitalopram	8-weeks of treatment followed by 1-week taper down period
OTHER	Placebo	Matching oral administration of inactive substance once daily

Timeline

• Start date: 2019-05-30
• Primary completion: 2021-09-20
• Completion: 2021-09-20
• First posted: 2019-04-23
• Last updated: 2022-11-14
• Results posted: 2022-11-14

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated drug study