Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06216535

Escitalopram in Asthma Patients With Frequent Exacerbation

Led by University of Texas Southwestern Medical Center · Updated on 2026-01-26

105

Participants Needed

1

Research Sites

210 weeks

Total Duration

On this page

Sponsors

U

University of Texas Southwestern Medical Center

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), such as escitalopram are widely used for mood and anxiety disorders. However, they have also been explored, with promising findings, for a variety of disorders outside of psychiatry. Clinical studies of SSRIs in depressed people with asthma were associated with decreased asthma exacerbations and improvement in asthma control. In this study, the number of asthma exacerbations will be assessed as the primary outcome measure in patients using escitalopram vs. placebo.

CONDITIONS

Official Title

Escitalopram in Asthma Patients With Frequent Exacerbation

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Moderate to severe persistent asthma
  • Currently treated with medium to high dose inhaled corticosteroids and long-acting beta-agonist therapy
  • Had three or more severe asthma exacerbations requiring at least 3 days of systemic corticosteroids in the past year
  • Between 18 and 75 years old, male or female sex, English or Spanish speaking
  • Clinically stable with no recent exacerbations, infections, or changes in asthma controller therapy for at least 4 weeks before study entry
  • Biologic asthma therapy allowed if started at least 6 months prior to randomization
Not Eligible

You will not qualify if you...

  • Current substance use disorder or current tobacco use or more than 10 pack-years lifetime smoking
  • Current episode of major depressive disorder, bipolar disorder, schizophrenia, or schizoaffective disorder
  • Included in vulnerable populations such as intellectual disability, severe cognitive impairment, inmates, pregnant or nursing women, or women of childbearing potential not using approved birth control or abstinence
  • Currently taking an antidepressant medication (except non-SSRI/SNRI antidepressants prescribed at subtherapeutic doses for non-depression reasons)
  • High suicide risk defined as more than one past suicide attempt or any attempt within the past 12 months
  • Severe or life-threatening medical illness or clinically significant laboratory or ECG abnormalities at baseline

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UT Southwestern, 1440 Empire Central, Ste. LD4.100

Dallas, Texas, United States, 75247

Actively Recruiting

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Research Team

R

Reagan Volzer, M.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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