Actively Recruiting
Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)
Led by University of Cincinnati · Updated on 2024-08-29
132
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
Sponsors
U
University of Cincinnati
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed assent and consent
- Patient and parent/guardian fluent in English
- Age 12 to 17 years inclusive at first visit
- Meets DSM-5 criteria for generalized, social, or separation anxiety disorder confirmed by MINI-KID
- Pediatric Anxiety Rating Scale score of 15 or higher at Visits 1 and 2
- No new psychotherapy started within 8 weeks of screening; current therapy stable for at least 2 months prior to baseline
- Clinical Global Impressions-Severity score of 4 or higher at Visits 1 and 2
- Caregiver willing to monitor safety, provide patient information, and oversee medication administration
- No significant abnormalities on physical exam and EKG
- Negative pregnancy test at Visit 1 for females
- Negative urine drug screen at Visit 1
- Sexually active patients must use reliable contraception during the study and for 30 days after, including surgical sterilization, oral contraceptives, transdermal contraceptives, vaginal contraceptive ring, implants, intrauterine device, or diaphragm plus condom
You will not qualify if you...
- Co-occurring DSM-5 mood disorder (except certain depressive disorders), eating, bipolar, or psychotic disorders
- Lifetime diagnosis of intellectual disability
- Significant history of trauma exposure
- SSRI treatment within 12 weeks of baseline or current psychiatric medication requiring over 5 half-lives washout
- History of non-response to more than 2 SSRIs
- Allergy, intolerance, non-response, or hypersensitivity to escitalopram
- Major neurological or medical illness or head trauma with 5 minutes or more loss of consciousness
- Alcohol or substance use disorder within past 6 months (nicotine allowed)
- Psychotherapy started within 8 weeks of screening or plans to start/change therapy during study
- Pregnant, breastfeeding, lactating, or planning pregnancy during or 30 days after study
- Positive urine pregnancy or drug test
- Lives more than 90 minutes from study center or unable to attend follow-ups
- Recent suicide attempt within 6 months or significant suicide risk
- Prolonged QTc interval (>450 ms males, >460 ms females)
- Unable to swallow capsules
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
Z
Zoe Neptune, BS
CONTACT
H
Heidi K Schroeder, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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