RECRUITING

Escitalopram in Asthma Patients With Frequent Exacerbation

Description

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

Study Overview

Study Details

Study overview

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.

Escitalopram in Asthma Patients With Frequent Exacerbation

Escitalopram in Asthma Patients With Frequent Exacerbation

Condition
Asthma
Intervention / Treatment

-

Contacts and Locations

Dallas

1440 Empire Central, Ste. LD4.100, Dallas, Texas, United States, 75247

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Moderate to severe persistent asthma
  • * Treatment with medium to high dose ICS and LABA therapy
  • * Three or more severe asthma exacerbations (requiring ≥ 3 days of systemic corticosteroids) in the past year
  • * Age 18-65 years old, male or female sex, English or Spanish speaking
  • * Participants will be required to be clinically stable with no recent exacerbations, infections or changes in asthma controller therapy for at least 4 weeks before study entry
  • * Biologic therapy for asthma (e.g., omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) will be allowed if started at least 6 months prior to randomization
  • * Current substance use disorder and/or current tobacco use or greater than 10 pack-years lifetime use
  • * A current MDD episode as well as bipolar disorder, schizophrenia, or schizoaffective disorder
  • * Vulnerable populations including intellectual disability or other severe cognitive impairment, inmates, pregnant or nursing women or women of childbearing age who will not use UT Southwestern IRB-approved methods of birth control or abstinence during the study
  • * Currently taking an antidepressant (antidepressants that are not SSRIs nor SNRIs prescribed for an indication other than depression at subtherapeutic doses are acceptable)
  • * High risk for suicide defined as \> 1 past suicide attempts or any attempt within the past 12 months
  • * Severe or life-threatening medical illness that would make completion of study unlikely or clinically significant laboratory or ECG findings at baseline

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Sherwood Brown, M.D, Ph.D, MBA, PRINCIPAL_INVESTIGATOR, UTSW Medical Center

Study Record Dates

2029-06-01