RightFit
RecruitingPhase 2

Escitalopram in Asthma Patients With Frequent Exacerbation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The primary outcome measure will be the number of times systemic corticosteroids are given for an asthma exacerbation with the Asthma Control Questionnaire as a secondary outcome measure."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether escitalopram, an antidepressant, reduces asthma flare-ups compared with a placebo (a pill with no active medicine). It is for adults ages 18–75 with moderate to severe asthma and frequent severe flare-ups.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have ongoing moderate to severe asthma.
  • Use a medium- to high-dose inhaled steroid and a long-acting medicine that helps keep airways open (LABA).
  • Had at least 3 severe asthma flare-ups in the past year, each needing steroid pills or shots for at least 3 days.
  • Are 18–75 years old and speak English or Spanish. All sexes may join.
  • Have had no flare-ups, infections, or changes in regular asthma medicines for at least 4 weeks before joining.
  • If using a biologic asthma medicine, which targets parts of the immune system, started it at least 6 months before study group assignment.

Who can't join

  • Have a current substance use disorder, use tobacco now, or have smoked more than 10 pack-years total (such as 1 pack a day for 10 years).
  • Have a current episode of major depression, bipolar disorder, schizophrenia, or schizoaffective disorder.
  • Have an intellectual disability or other severe problems with thinking, or are in prison.
  • Are pregnant or breastfeeding, or could become pregnant and will not use study-approved birth control or avoid sex during the study.
  • Take an antidepressant now. Some low-dose antidepressants used for reasons other than depression are allowed, but not those in the SSRI or SNRI groups.
  • Have attempted suicide more than once, or had any suicide attempt in the past 12 months.
  • Have a severe or life-threatening illness that makes finishing the study unlikely, or important abnormal results on starting lab tests or an ECG (a heart rhythm test).

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TX