RecruitingAnxietyDepressive Symptoms

Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)

Eligible age

12–17 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.

Sponsor: University of Cincinnati

✓ Written, informed assent and consent.
✓ Patients, parent/guardian/LAR must be fluent in the English.
✓ 12 to 17 years of age, inclusive, at Screening.
✓ Patients must meet DSM-512 criteria for generalized, social and/or separation anxiety disorder and/or panic disorder, confirmed by the MINI-KID.
✓ 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.
✓ Negative pregnancy test at Screening in females.
✓ Negative urine drug screen at Screening.

✕ DSM-512 diagnosis other than generalized anxiety, social anxiety, separation anxiety or panic disorder(s) that is the primary focus of treatment.
✕ A history of intellectual disability.
✕ 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.
✕ Allergy, intolerance, non-response or hypersensitivity to escitalopram or duloxetine.
✕ Subjects taking other medications that require a taper or washout of more than 5 days.
✕ Patients who have initiated/terminated psychotherapy/behavior therapy within 1 month before Visit 2 (Baseline), or who plan to initiate/change said therapies during the course of the study will be excluded; if the patient is engaged in psychotherapy, it must have been stable for 1 month prior to baseline.
✕ A clinically-significant medical illness.
✕ QTc \>450 in males / \>460 in females (prolonged QTc based on American Heart Association recommendations for Standardization and Interpretation of the EKG81

Cincinnati

Source: ClinicalTrials.gov · NCT04245436 · last updated 2024-08-29