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

Recruiting now · Phase 4

Conditions studied: Anxiety

In brief

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 facts

Study ID

NCT04623099

Run by

University of Cincinnati

People needed

132

Starts

2021-03-08

Expected to finish

2026-12-01

Last updated by the study team

2024-08-29

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Written, informed assent and consent.
• Patients, parent/guardian must be fluent in the English.
• 12 to 17 years of age, inclusive, at Visit 1.
• Patients must meet DSM-512 criteria for generalized, social and/or separation anxiety disorder, confirmed by the MINI-KID.
• PARS score ≥15 at Visit 1 and Visit 2.
• No initiation of psychotherapy within 8 weeks of screening (Visit 1). Current therapy much be stable for ≥2 months prior to baseline (Visit 2).
• Clinical Global Impressions-Severity (CGI-S) score ≥4 at Visits 1 \& 2.
• 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.
• No clinically significant abnormalities on physical examination and EKG.
• Negative pregnancy test at Visit 1 in females.
• Negative urine drug screen at Visit 1.
• Sexually active patients must practice a reliable method of contraception that will continue for the duration of the study and for a minimum of 30 days following the end of study participation. Reliable methods of contraception are defined below; other forms of contraceptives (pharmacological and/or non-pharmacological) are not accepted:
• Surgical sterilization
• Oral contraceptives (e.g. estrogen-progestin combination or progestin)
• Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)
• Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II/Jadelle)
• An intrauterine device
• Diaphragm plus condom. -

You may not qualify if…

• 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.
• A lifetime diagnosis of an intellectual disability.
• A significant history of trauma exposure.
• 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.
• Allergy, intolerance, non-response or hypersensitivity to escitalopram. Major neurological or medical illness or head trauma with ≥5 minutes loss of consciousness.
• Alcohol or substance use disorder within the past 6 months (nicotine use is permitted).
• Psychotherapy initiated within 8 weeks of screening (Visit 1), or plans to initiate/change therapy during the study.
• Pregnant, breastfeeding, lactating, and/or planning to become pregnant during the study or within 30 days following the end of study participation.
• Positive urine pregnancy test.
• A positive urine drug screen.
• Patient lives >90 minutes from UC or unable to attend follow-up visits. Suicide risk as determined by either: (1) any suicide attempt within the past 6 months and/or (2) significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the Investigator.
• QTc >450 in males or >460 in females (prolonged QTc based on American Heart Association recommendations for Standardization and Interpretation of the EKG
• Patients who are unable to swallow capsules.

Where it is running

• University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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