RecruitingPhase 4NCT04623099

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


Sponsor

University of Cincinnati

Enrollment

132 participants

Start Date

Mar 8, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study (called PrEcISE) is testing whether customizing the antidepressant escitalopram based on a teenager's genetics can improve its effectiveness and reduce side effects for adolescents with anxiety disorders. **You may be eligible if...** - You are between 12 and 17 years old - You (and your parent/guardian) are fluent in English and can provide consent and assent - You have been diagnosed with generalized anxiety disorder, social anxiety disorder, or separation anxiety disorder - Your anxiety is moderate to severe based on clinical rating scales - You are not starting new therapy within 8 weeks of screening, or your current therapy has been stable for at least 2 months **You may NOT be eligible if...** - You have significant medical or laboratory abnormalities - You have a psychiatric condition other than anxiety (such as psychosis or bipolar disorder) - You are pregnant - You have a significant history of suicidal behavior Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience

Cincinnati, Ohio, United States

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NCT04623099


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