NCT06216535 Escitalopram in Asthma Patients With Frequent Exacerbation
| NCT ID | NCT06216535 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 105 participants in total. It began in 2025-05-19 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Sherwood Brown, M.D, Ph.D, MBA
PRINCIPAL INVESTIGATOR
UTSW Medical Center
Frequently Asked Questions
Who can join the NCT06216535 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06216535 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06216535 currently recruiting?
Yes, NCT06216535 is actively recruiting participants. Contact the research team at reagan.volzer@utsouthwestern.edu for enrollment information.
Where is the NCT06216535 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06216535 clinical trial?
NCT06216535 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Sherwood Brown, M.D, Ph.D, MBA at UTSW Medical Center. The trial plans to enroll 105 participants.
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