RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-03-08

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04623099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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. -	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.

Inclusion Criteria

Exclusion 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. -

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.

Contacts and Locations

Study Contact

Zoe Neptune, BS

CONTACT

(513) 558-2866

neptunza@uc.edu

Heidi K Schroeder, BS

CONTACT

(513) 558-4422

heysehk@uc.edu

Principal Investigator

Jeffrey R Strawn, MD

PRINCIPAL_INVESTIGATOR

University of Cincinnati

Laura B Ramsey, PhD

PRINCIPAL_INVESTIGATOR

Children's Mercy Kansas City

Study Locations (Sites)

University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience

Cincinnati, Ohio, 45219

United States

Collaborators and Investigators

Sponsor: University of Cincinnati

Jeffrey R Strawn, MD, PRINCIPAL_INVESTIGATOR, University of Cincinnati
Laura B Ramsey, PhD, PRINCIPAL_INVESTIGATOR, Children's Mercy Kansas City

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-08

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2021-03-08

Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

Kids
Anxiety

Additional Relevant MeSH Terms

Anxiety