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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT04623099
Phase
PHASE4
Status
Recruiting
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Conditions

  • Anxiety

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Escitalopram — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 8, 2021
Status verified
Aug 2024
Primary completion
Jun 30, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Standard dosing
    Patients randomized to standard dosing (std) will initiate escitalopram at 5 mg daily and will then increase to 20 mg/day at week 4.
  • Experimental: Pharmacogenetically-guided escitalopram dosing
    Patients randomized to PGx-guided treatment, escitalopram titration will be based on CYP2C19 phenotype and predicted escitalopram exposure. In poor metabolizers (PM), escitalopram will be initiated at 5 mg daily and increased to 10 mg daily at week 4.

Primary Outcome Measure

Pediatric Anxiety Rating Scale severity score [ Time Frame: Baseline to Week 12/Early Termination ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Cincinnati, Department of Psychiatry & Behavioral NeuroscienceCincinnatiOhio45219
Zoe A Neptune, BS
[email protected]
513-558-2866
Heidi K Schroeder, BS
[email protected]
513-558-4422

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By research site
University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience· Cincinnati, OH

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