Status:
RECRUITING
Escitalopram in Asthma Patients With Frequent Exacerbation
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 promisin...
Detailed Description
A 24-week, randomized, double-blind, placebo-controlled trial of escitalopram will be conducted in 105 people with moderate to severe persistent asthma who, despite treatment with medium to high dose ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06216535
Start Date
May 19 2025
End Date
June 1 2029
Last Update
July 22 2025
Active Locations (1)
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1
UT Southwestern, 1440 Empire Central, Ste. LD4.100
Dallas, Texas, United States, 75247