Acute, Double-Blind, Adaptively Randomized Treatment With Duloxetine or Escitalopram Followed by Open-Label Naturalistic Follow-Up in Adolescents With Anxiety

What this Trial Is About

Researchers are studying adolescents aged 12 to 17 with anxiety disorders, including those who also have depressive symptoms, to understand how they respond to two different antidepressant medications: duloxetine and escitalopram. The study aims to identify factors that predict how well and how quickly these medications work, as well as factors that influence long-term treatment success, relapse rates, and the development of depressive disorders in anxious adolescents. This is a phase 4, double-blind, randomized trial sponsored by the University of Cincinnati. Participants are randomly assigned to receive either duloxetine or escitalopram during an acute treatment phase. Duloxetine treatment starts at 30 mg once daily and may increase up to 120 mg daily by Week 8, while escitalopram starts at 5 mg once daily, increasing to 20 mg by Week 6 if needed. After the acute treatment phase, participants enter an open-label naturalistic follow-up period to monitor long-term outcomes. Throughout the study, participants undergo regular assessments including the Pediatric Anxiety Rating Scale (PARS) and Clinical Global Impression of Severity (CGI-S) to measure anxiety severity and overall clinical status up to 24 months. Safety is closely monitored through physical exams, pregnancy and drug tests, and caregiver involvement. The study tracks medication adherence and collects information on safety and treatment response over the long term, with total participation lasting up to two years.

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