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

NCT03924323 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2022-11-14

Study results available
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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

DRUG

Escitalopram

8-weeks of treatment followed by 1-week taper down period

OTHER

Placebo

Matching oral administration of inactive substance once daily

Sponsors & Collaborators

Principal Investigators

  • ALLERGAN INC. · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2021-09-20
Completion
2021-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03924323 on ClinicalTrials.gov