Acute, Double-blind, Adaptively Randomized Treatment With Duloxetine or Escitalopram, Followed by Open-label Naturalistic Follow-up.
University of Cincinnati
Summary
Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.
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.
Eligibility
- Age range
- 12–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Written, informed assent and consent. * Patients, parent/guardian/LAR must be fluent in the English. * 12 to 17 years of age, inclusive, at Screening. * Patients must meet DSM-512 criteria for generalized, social and/or separation anxiety disorder and/or panic disorder, confirmed by the MINI-KID. * Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of the investigational product. * No clinically significant abnormalities on physical examination. * Negati…
Interventions
- DrugDuloxetine
Encapsulated duloxetine 30 mg, 60 mg; once-daily
- DrugEscitalopram
Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily
Location
- University of CincinnatiCincinnati, Ohio