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

Last updated: August 28, 2024
Sponsor: University of Cincinnati
Overall Status: Active - Recruiting

Phase

4

Condition

Depression

Treatment

Escitalopram

Duloxetine

Clinical Study ID

NCT04245436
Strawn AtLAS-A
  • Ages 12-17
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 separationanxiety disorder and/or panic disorder, confirmed by the MINI-KID.

  • Caregiver who is willing to consent to be responsible for safety monitoring of thepatient, provide information about the patient's condition, oversee theadministration 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 daysfollowing the end of study participation. Reliable methods of contraception aredefined below; other forms of contraceptives (pharmacological and/ornon-pharmacological) are not accepted:

  1. Surgical sterilization

  2. Oral contraceptives (e.g. estrogren-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.

Exclusion

Exclusion Criteria:

  • DSM-512 diagnosis other than generalized anxiety, social anxiety, separation anxietyor 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 6months and/or (2) significant risk at Visit 1 (Screening) or Visit 2 (Baseline), asjudged by the Investigator.

  • Allergy, intolerance, non-response or hypersensitivity to escitalopram orduloxetine.

  • Subjects taking other medications that require a taper or washout of more than 5days.

  • Patients who have initiated/terminated psychotherapy/behavior therapy within 1 monthbefore Visit 2 (Baseline), or who plan to initiate/change said therapies during thecourse of the study will be excluded; if the patient is engaged in psychotherapy, itmust 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 HeartAssociation recommendations for Standardization and Interpretation of the EKG81

  • Alcohol or substance use disorder within the past 6 months (nicotine use ispermitted).

  • Positive urine pregnancy test/pregnancy or breast feeding.

  • A positive urine drug screen.

  • Patients who are unable to swallow capsules.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Escitalopram
Phase: 4
Study Start date:
January 01, 2020
Estimated Completion Date:
August 31, 2025

Study Description

To identify predictors of the magnitude and trajectory of response to flexibly-dosed duloxetine and escitalopram response in adolescents with anxiety, including those with depressive symptoms. And also to examine long-term predictors of sustained response and relapse in adolescents. To examine predictors of developing depressive disorders in anxious adolescents.

Connect with a study center

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

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