Escitalopram Treatment for Pediatric Anxiety

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.
Ready to participate?

Review the details below, then apply to join this clinical trial.

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
Who this trial is looking for

This trial is looking for young people ages 12 to 17 with anxiety disorders. Participants will receive a type of medication called escitalopram, either in a standard dose or one adjusted based on genetic testing, over 12 weeks.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 12 and 17 years old.
  • I have been diagnosed with anxiety disorders.
  • I can read and understand English.
  • I have a caregiver who can help monitor my safety.
  • I have not started psychotherapy in the last 8 weeks.
  • I have a certain level of anxiety as measured by a test.
  • I have not had any significant health issues based on physical exams.
  • I am not pregnant or breastfeeding.

You may not be able to join if

  • I have a mood disorder or other serious mental condition.
  • I have been treated with certain antidepressants in the past 12 weeks.
  • I have a history of alcohol or substance use disorder in the last 6 months.
  • I have had a suicide attempt in the past 6 months.
  • I have significant heart-related issues.
  • I cannot swallow capsules.
  • I live more than 90 minutes away from the study location.
  • I am pregnant, breastfeeding, or planning to become pregnant.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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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