RecruitingAnxiety
Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)
Eligible age
12–17 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
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About this study
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.
Sponsor: University of Cincinnati
You may qualify if…
- ✓ 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. PARS score ≥15 at Visit 1 and Visit 2.
- ✓ 6. No initiation of psychotherapy within 8 weeks of screening (Visit 1). Current therapy much be stable for ≥2 months prior to baseline (Visit 2).
- ✓ 7. Clinical Global Impressions-Severity (CGI-S) score ≥4 at Visits 1 \& 2.
- ✓ 8. Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of the investigational product.
You may not qualify if…
- ✕ 1. Co-occurring DSM-5 mood disorder (except persistent depressive disorder, unspecified depressive disorder, provided that the primary diagnosis is an anxiety disorder), eating, bipolar or psychotic disorders.
- ✕ 2. A lifetime diagnosis of an intellectual disability.
- ✕ 3. A significant history of trauma exposure.
- ✕ 4. A history of SSRI treatment within 12 weeks of baseline or current treatment with a medication with psychiatric effects that requires \>5 half-lives for washout History of non-response to \>2 SSRIs.
- ✕ 5. Allergy, intolerance, non-response or hypersensitivity to escitalopram. Major neurological or medical illness or head trauma with ≥5 minutes loss of consciousness.
- ✕ 6. Alcohol or substance use disorder within the past 6 months (nicotine use is permitted).
- ✕ 7. Psychotherapy initiated within 8 weeks of screening (Visit 1), or plans to initiate/change therapy during the study.
- ✕ 8. Pregnant, breastfeeding, lactating, and/or planning to become pregnant during the study or within 30 days following the end of study participation.
Where it's recruiting
Ohio
Cincinnati
Source: ClinicalTrials.gov · NCT04623099 · last updated 2024-08-29