Recruiting
Phase 2

Escitalopram

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06216535

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Escitalopram

Placebo

Study Details

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.

Conditions

Asthma

Study ID

NCT06216535

Start date

May 19, 2025

Status verified date

Jan, 2026

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Participants will receive an inactive placebo by mouth using the same administration schedule as for escitalopram.

active comparator: Escitalopram

Participants will take oral escitalopram 10 mg per day for two weeks, followed by oral escitalopram 20 mg per day for 22 weeks. Participants will take oral escitalopram 10 mg per day for one week at the final study visit.

Interventions

Escitalopram

Escitalopram is an FDA-approved SSRI antidepressant that is administered by mouth

Placebo

Inactive placebo comparator

Primary outcome measure

  • Total number of severe asthma exacerbations [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Reagan Volzer, M.S.

214-645-6963reagan.volzer@utsouthwestern.edu

Locations

UT Southwestern, 1440 Empire Central, Ste. LD4.100

Recruiting

Dallas, Texas, United States, 75247

Contacts

Reagan Volzer, MS

214-645-6963Reagan.Volzer@UTSouthwestern.edu

Génesis González Álvarez, MS

214-645-6967Genesis.GonzalezAlvarez@UTSouthwestern.edu

Principal Investigator:

Sherwood Brown, M.D, Ph.D

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • Escitalopram
  • SSRI
  • Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-01-26.