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.
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