NCT06216535RecruitingPhase 2
Escitalopram in Asthma Patients With Frequent Exacerbation
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 11 Jan 2024
- Start date
- May 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Asthma
- NCT number
- NCT06216535
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 105
- From May 2025 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking an antidepressant (antidepressants that are not SSRIs nor SNRIs prescribed for an indication other than depression at subtherapeutic doses are acceptable)
Other illness
- 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
Lab values
- Severe or life-threatening medical illness that would make completion of study unlikely or clinically significant laboratory or ECG findings at baseline
Age
- 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
Other
- High risk for suicide defined as \> 1 past suicide attempts or any attempt within the past 12 months
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern, 1440 Empire Central, Ste. LD4.100 Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.