NCT04623099 Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)
| NCT ID | NCT04623099 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Cincinnati |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2021-03-08 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 132 participants in total. It began in 2021-03-08 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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. 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. 9. No clinically significant abnormalities on physical examination and EKG. 10. Negative pregnancy test at Visit 1 in females. 11. Negative urine drug screen at Visit 1. 12. 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: 1. Surgical sterilization 2. Oral contraceptives (e.g. estrogen-progestin combination or progestin) 3. Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera) 4. Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II/Jadelle) 5. An intrauterine device 6. Diaphragm plus condom. - Exclusion Criteria: 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. 9. Positive urine pregnancy test. 10. A positive urine drug screen. 11. 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. 12. QTc \>450 in males or \>460 in females (prolonged QTc based on American Heart Association recommendations for Standardization and Interpretation of the EKG 13. Patients who are unable to swallow capsules.
Contact & Investigator
Jeffrey R Strawn, MD
PRINCIPAL INVESTIGATOR
University of Cincinnati
Frequently Asked Questions
Who can join the NCT04623099 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04623099 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04623099 currently recruiting?
Yes, NCT04623099 is actively recruiting participants. Contact the research team at neptunza@uc.edu for enrollment information.
Where is the NCT04623099 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT04623099 clinical trial?
NCT04623099 is sponsored by University of Cincinnati. The principal investigator is Jeffrey R Strawn, MD at University of Cincinnati. The trial plans to enroll 132 participants.
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