RecruitingPhase 4NCT04245436

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

Acute, Double-blind, Adaptively Randomized Treatment With Duloxetine or Escitalopram, Followed by Open-label Naturalistic Follow-up.

Sponsor

University of Cincinnati

Enrollment

60 participants

Start Date

Jan 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 17 Years

Written, informed assent and consent.
Patients, parent/guardian/LAR must be fluent in the English.
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.
Sexually active patients must practice a reliable method of contraception (Section 15.0) 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. estrogren-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.

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
Alcohol or substance use disorder within the past 6 months (nicotine use is permitted).
Positive urine pregnancy test/pregnancy or breast feeding.
A positive urine drug screen.
Patients who are unable to swallow capsules.