Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)
University of Cincinnati
Summary
This double-blind, 12-week study will consist include132 anxious youth who are randomized (1:1) to standard or pharmacogenetically-guided escitalopram dosing. Block randomization (1:1) will be stratified by sex and metabolizer status.
Description
This randomized, controlled trial compares pharmacogenetically-guided and standard dosing of escitalopram in adolescents (12-17 years of age) with anxiety disorders. In this study, the investigators will examine these two dosing strategies in terms of efficacy (Aim 1) and tolerability (Aim 2). The investigators propose to recruit 132 adolescents (age 12-17 years, inclusive) with generalized, separation and/or social anxiety disorder (pediatric anxiety trial).1 This will allow investigators to evaluate whether pharmacogenetically-guided escitalopram dosing improves efficacy and tolerability in…
Eligibility
- Age range
- 12–17 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Written, informed assent and consent. 2. Patients, parent/guardian must be fluent in the English. 3. 12 to 17 years of age, inclusive, at Visit 1. 4. Patients must meet DSM-512 criteria for generalized, social and/or separation anxiety disorder, confirmed by the MINI-KID. 5. PARS score ≥15 at Visit 1 and Visit 2. 6. No initiation of psychotherapy within 8 weeks of screening (Visit 1). Current therapy much be stable for ≥2 months prior to baseline (Visit 2). 7. Clinical Global Impressions-Severity (CGI-S) score ≥4 at Visits 1 \& 2. 8. Caregiver who is willing to consent…
Interventions
- DrugEscitalopram
Escitalopram is FDA-approved for the treatment of major depressive disorder (MDD) in adolescents (12-17 years of age) and is commonly prescribed for adolescents with anxiety disorders.
Location
- University of Cincinnati, Department of Psychiatry & Behavioral NeuroscienceCincinnati, Ohio