Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)

Recruiting Phase 4 Interventional Study
Anxiety
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
12 – 17
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
132 (estimated)
Sponsor
University of Cincinnati · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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. …
Contacts

Zoe Neptune, BS

(513) 558-2866

neptunza@uc.edu

CONTACT

Heidi K Schroeder, BS

(513) 558-4422

heysehk@uc.edu

CONTACT