← Back to Search

Serotonin-Norepinephrine Reuptake Inhibitor

Duloxetine vs Escitalopram for Depression (AtLAS-A Trial)

Phase 4
Recruiting
Led By Jeffrey R Strawn, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)
Surgical sterilization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24 months (early term)
Awards & highlights

AtLAS-A Trial Summary

This trial is testing whether duloxetine or escitalopram are better at treating depression, and then will see how well patients do after treatment.

Who is the study for?
The AtLAS-A trial is for English-speaking adolescents aged 12-17 with anxiety disorders as per DSM-5 criteria. They must have a caregiver to monitor safety and manage medication, no significant physical health issues, and agree to use reliable contraception if sexually active. Excluded are those with intellectual disabilities, recent suicide risk, allergies or non-response to the study drugs, certain medication regimens or psychotherapy changes within the last month.Check my eligibility
What is being tested?
This study tests two antidepressants: Duloxetine and Escitalopram in teens with anxiety. It starts with a double-blind phase where neither participants nor researchers know who's getting which drug. After that comes an open-label follow-up without this blinding.See study design
What are the potential side effects?
Possible side effects of Duloxetine and Escitalopram include nausea, dry mouth, sleepiness or insomnia, dizziness upon standing up too fast (orthostatic hypotension), decreased appetite leading to weight loss, increased sweating.

AtLAS-A Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I use skin patches or injections for birth control.
Select...
I have undergone a procedure to prevent pregnancy permanently.
Select...
I am currently using oral contraceptives.
Select...
I use a vaginal ring or contraceptive implant for birth control.
Select...
I have been diagnosed with an anxiety disorder.
Select...
My drug test results were negative.
Select...
I am between 12 and 17 years old.

AtLAS-A Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24 months (early term)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 months (early term) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score
Change from Baseline in the Clinical Global Impression of Severity (CGI-S)

AtLAS-A Trial Design

2Treatment groups
Active Control
Group I: DuloxetineActive Control1 Intervention
Patients randomized to duloxetine, treatment will be initiated at 30 mg qAM through Week 4 (V5) (consistent with the registration trial for duloxetine in pediatric patients with generalized anxiety disorder). Then, duloxetine will be increased to 60 mg qAM at Week 4 (V5) and will be continued at this dose until Week 6 (V6) or the end of the acute phase of the study. Beginning at Week 6 (V6), duloxetine may be increased to 90 mg daily and at Week 8 (V7), may be increased to 120 mg daily.
Group II: EscitalopramActive Control1 Intervention
Patients randomized to escitalopram, will initiate treatment at 5 mg qAM for 1 week and then 10 mg qAM (the recommended starting dose for adolescents 12-17 years and the dose used in the pediatric registration trials). After Week 4 (V5), escitalopram will be increased to 15 mg and this dose will be continued until either Week 6 (V6) or the end of the acute phase of the study; however, at Week 6 (V6), escitalopram may be increased to 20 mg qAM based on efficacy.

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,326 Total Patients Enrolled
6 Trials studying Anxiety
768 Patients Enrolled for Anxiety
Jeffrey R Strawn, MDPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
132 Total Patients Enrolled
1 Trials studying Anxiety
132 Patients Enrolled for Anxiety

Media Library

Duloxetine (Serotonin-Norepinephrine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04245436 — Phase 4
Anxiety Research Study Groups: Duloxetine, Escitalopram
Anxiety Clinical Trial 2023: Duloxetine Highlights & Side Effects. Trial Name: NCT04245436 — Phase 4
Duloxetine (Serotonin-Norepinephrine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04245436 — Phase 4
Anxiety Patient Testimony for trial: Trial Name: NCT04245436 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must a person meet to be eligible for this research study?

"The purpose of this trial is to assess the efficacy and safety of a medication for 60 minors between 12-17 years old who suffer from depression. Aspiring patients must satisfy criteria such as: falling within the specified age range, submitting a negative pregnancy test (if applicable), having DSM-5 diagnosed generalized anxiety disorder or panic disorder confirmed by MINI-KID, displaying no physical abnormalities, and being surgically sterilized in some cases."

Answered by AI

Has Duloxetine been investigated in prior research?

"Presently, out of 41 live trials looking into duloxetine's efficacy, 8 are in Phase 3. With ample clinical trial sites spread across Redwood City and beyond - a total of 820 locations - the research is progressing well."

Answered by AI

What therapeutic effects is Duloxetine typically known to produce?

"Duloxetine has been demonstrated to be effective in managing diabetic peripheral neuropathy, knee-related issues, and major depressive disorder."

Answered by AI

Does Duloxetine pose any serious health risks to individuals?

"With Phase 4 status, Duloxetine is estimated to have a safety rating of 3 on our scale. This classification signifies that the medication has been approved for general use."

Answered by AI

Does this trial cater to individuals aged 55 and older?

"To be accepted into this trial, the patient must fall in the age bracket of 12 to 17 years old. This specific study has 220 participants under 18 and 1,017 over 65 enrolled."

Answered by AI

What is the approximate magnitude of participants in this trial?

"Yes, clinicaltrials.gov confirms that this research is actively looking for participants; the trial was originally posted on January 1st 2020 and last updated February 14th 2022. For successful completion of the study, 60 individuals are needed to participate across a single site."

Answered by AI

Is this medical experiment actively seeking participants?

"Indeed, the details on clinicaltrials.gov suggests that this trial is actively searching for participants. It was posted online on January 1st 2020 and most recently updated February 14th 2022. The research team are looking to recruit a total of 60 patients from one site."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
What site did they apply to?
University of Cincinnati
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I currently take Cymbalta & it works occasionally but not 100 percent.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Is there a compensation for this? Also for travel?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)
Jeffrey Strawn, MD 2020. "Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04245436.
All > Depression Cincinnati
~2 spots leftby Jul 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top