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Recruiting NCT04245436

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

Phase IV Interventional Anxiety Depressive Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Duloxetine, Escitalopram.
Who it may be relevant to
Registry conditions: Anxiety, Depressive Symptoms. Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed 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.

Interventions

  • Drug Duloxetine
    Encapsulated duloxetine 30 mg, 60 mg; once-daily
  • Drug Escitalopram
    Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily

Primary outcome measures

  • Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score [Time frame: Baseline to Week 24 months (Early Term)]
  • Change from Baseline in the Clinical Global Impression of Severity (CGI-S) [Time frame: Baseline to Week 10 (Early Term)]

Eligibility criteria

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 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Cincinnati — Cincinnati

Identifiers

NCT: NCT04245436 · Strawn AtLAS-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗