Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE) (PrEcISE)
Anxiety
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Kids, Anxiety
Eligibility Criteria
Inclusion Criteria:
- 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. -
Exclusion Criteria:
- 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.
Sites / Locations
- University of Cincinnati, Department of Psychiatry & Behavioral NeuroscienceRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Experimental
Standard dosing
Pharmacogenetically-guided escitalopram dosing
Patients randomized to standard dosing (std) will initiate escitalopram at 5 mg daily and will then increase to 20 mg/day at week 4.
Patients randomized to PGx-guided treatment, escitalopram titration will be based on CYP2C19 phenotype and predicted escitalopram exposure. In poor metabolizers (PM), escitalopram will be initiated at 5 mg daily and increased to 10 mg daily at week 4.