Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Encapsulated duloxetine 30 mg, 60 mg; once-daily
Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily
University of Cincinnati
Cincinnati, Ohio, United States
RECRUITINGChange from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score
The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders in children and adolescents. The PARS score is derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7)
Time frame: Baseline to Week 24 months (Early Term)
Change from Baseline in the Clinical Global Impression of Severity (CGI-S)
CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.
Time frame: Baseline to Week 10 (Early Term)
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