Actively Recruiting
Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)
Led by University of Cincinnati · Updated on 2024-08-29
60
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.
CONDITIONS
Official Title
Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written, informed assent and consent.
- Patient and caregiver fluent in English.
- Age between 12 and 17 years at screening.
- Meets DSM-512 criteria for generalized, social, separation anxiety disorder, or panic disorder confirmed by MINI-KID.
- Caregiver willing to monitor safety, provide information, and oversee medication.
- No clinically significant physical exam abnormalities.
- Negative pregnancy test for females at screening.
- Negative urine drug screen at screening.
- Sexually active patients must use reliable contraception during and for 30 days after study.
- Reliable contraception includes surgical sterilization, oral contraceptives, transdermal contraceptives, vaginal ring, contraceptive implants, intrauterine device, or diaphragm plus condom.
You will not qualify if you...
- DSM-512 diagnosis other than the specified anxiety disorders as primary focus.
- History of intellectual disability.
- Suicide attempt in past 6 months or significant suicide risk at screening or baseline.
- Allergy, intolerance, or hypersensitivity to escitalopram or duloxetine.
- Taking medications requiring taper or washout over 5 days.
- Started or ended psychotherapy/behavior therapy within 1 month before baseline or plans to change therapy during study; stable psychotherapy for at least 1 month prior if ongoing.
- Clinically significant medical illness.
- Prolonged QTc: >450 ms in males, >460 ms in females.
- Alcohol or substance use disorder within past 6 months (nicotine allowed).
- Positive pregnancy test, pregnancy, or breastfeeding.
- Positive urine drug screen.
- Unable to swallow capsules.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
J
Jeffrey R Strawn, MD
CONTACT
H
Heidi K Schroeder, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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