Escitalopram in Asthma Patients With Frequent Exacerbation
Recruiting · NCT06216535 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas Southwestern Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
EscitalopramPlacebo
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion 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 18-75 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, tezepelumab) will be allowed if started at least 6 months prior to randomization
Exclusion criteria
- 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
Where it is running
1 location listed across 1 US state.
- UT Southwestern, 1440 Empire Central, Ste. LD4.100 - Dallas, Texas, United States