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

Conditions

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

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

Active Comparator: Duloxetine
Patients randomized to duloxetine, treatment will be initiated at 30 mg qAM through Week 4 (V5) (consistent with the registration trial for duloxetine in pediatric patients with generalized anxiety disorder). Then, duloxetine will be increased to 60 mg qAM at Week 4 (V5) and will be continued at this dose until Week 6 (V6) or the end of the acute phase of the study. Beginning at Week 6 (V6), duloxetine may be increased to 90 mg daily and at Week 8 (V7), may be increased to 120 mg daily.
Active Comparator: Escitalopram
Patients randomized to escitalopram, will initiate treatment at 5 mg qAM for 1 week and then 10 mg qAM (the recommended starting dose for adolescents 12-17 years and the dose used in the pediatric registration trials). After Week 4 (V5), escitalopram will be increased to 15 mg and this dose will be continued until either Week 6 (V6) or the end of the acute phase of the study; however, at Week 6 (V6), escitalopram may be increased to 20 mg qAM based on efficacy.

Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score [ Time Frame: Baseline to Week 24 months (Early Term) ]

Facility	City	State	ZIP	Site coordinators
University of Cincinnati	Cincinnati	Ohio	45219	Jeffrey R Strawn, MD [email protected] 513-558-7700

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