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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 24 months (early term)

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I use skin patches or injections for birth control.

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I have undergone a procedure to prevent pregnancy permanently.

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I am currently using oral contraceptives.

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I use a vaginal ring or contraceptive implant for birth control.

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I have been diagnosed with an anxiety disorder.

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My drug test results were negative.

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I am between 12 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My mental health treatment has been stable for at least a month.

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I have a serious health condition.

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I cannot swallow capsules.

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I am on medication that cannot be stopped immediately and requires more than 5 days to safely stop.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 24 months (early term)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score

Change from Baseline in the Clinical Global Impression of Severity (CGI-S)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met