Extracellular Vesicles as Predictors of Antidepressant Outcomes in Pediatric Anxiety (EV-SOPRANO)
University of Cincinnati
Summary
A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.
Description
Randomized, double-blind, placebo-controlled trial of an evidence-based antidepressant, sertraline, in youth (N=120) with generalized, separation and/or social anxiety disorders, seeks to evaluate the predictive value of plasma EV signatures. Patients will be randomized to sertraline (25-200 mg/day) or placebo (3:1) and total plasma EVs will be collected at baseline and serially during the course of the 12-week treatment period.
Eligibility
- Age range
- 8–17 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria for Patients with Anxiety : * Written, informed assent and consent. * Patients, parent/guardian/LAR must be fluent in the English. * 8-17 years of age, inclusive, at Visit 1, and who have a parent/guardian/LAR. * Patients must meet DSM-5 criteria for generalized, social and/or separation anxiety disorder, confirmed by the MINI-KID with no lifetime history of mania, OCD or significant history of trauma exposure. * PARS score ≥15 at Visits 1 and 2. * Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patie…
Interventions
- Drugsertraline
Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)
Location
- University of CincinnatiCincinnati, Ohio