NCT04245436

Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)

Acute, Double-blind, Adaptively Randomized Treatment With Duloxetine or Escitalopram, Followed by Open-label Naturalistic Follow-up.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.

Detailed description

To identify predictors of the magnitude and trajectory of response to flexibly-dosed duloxetine and escitalopram response in adolescents with anxiety, including those with depressive symptoms. And also to examine long-term predictors of sustained response and relapse in adolescents. To examine predictors of developing depressive disorders in anxious adolescents.

Conditions

• Anxiety
• Depressive Symptoms

Interventions

Type	Name	Description
DRUG	Duloxetine	Encapsulated duloxetine 30 mg, 60 mg; once-daily
DRUG	Escitalopram	Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily

Timeline

• Start date: 2020-01-01
• Primary completion: 2025-07-01
• Completion: 2025-08-01
• First posted: 2020-01-29
• Last updated: 2024-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study