RECRUITING

Escitalopram in Asthma Patients With Frequent Exacerbation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Escitalopram in Asthma Patients With Frequent Exacerbation

Quick Facts

Study Start:2025-05-27

Study Completion:2029-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06216535

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Reagan Volzer, M.S.

CONTACT

214-645-6963

reagan.volzer@utsouthwestern.edu

Principal Investigator

Sherwood Brown, M.D, Ph.D, MBA

PRINCIPAL_INVESTIGATOR

UTSW Medical Center

Study Locations (Sites)

1440 Empire Central, Ste. LD4.100

Dallas, Texas, 75247

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-27

Study Completion Date2029-06-01

Study Record Updates

Study Start Date2025-05-27

Study Completion Date2029-06-01

Terms related to this study

Keywords Provided by Researchers

Escitalopram
SSRI
Adults

Additional Relevant MeSH Terms

Asthma