Clinical trial · Interventional
Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder
Escitalopram in the Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose is to determine if: 1) Escitalopram treatment will be associated with less oral corticosteroid use than placebo in outpatients with severe asthma and moderate or severe major depressive disorder (MDD). 2) Escitalopram treatment will be associated with greater improvement in asthma symptoms than placebo in outpatients with severe asthma and moderate or severe MDD. 3) Escitalopram treatment will be associated with greater depressive symptom remission rates than placebo in outpatients with severe asthma and moderate or severe MDD.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Moderate or Severe Major Depressive Disorder | — | UNRESOLVED | — |
| Severe Asthma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Escitalopram | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo Matching Escitalopram given orally daily (for a 12-week duration).
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Escitalopram
- description
- Once daily oral administration (for a 12-week duration) of 10 mg escitalopram tablets with an increase to 20 mg in those with a less than 30% decrease in HAM-D scores at week 4.
- interventionNames
- Drug: Escitalopram
Primary outcomes (6)
- measure
- HAM-D (Hamilton Rating Scale for Depression)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Current HAM-D score of ≥ 20 * Patients with severe asthma (defined as asthma requiring three or more course of oral corticosteroids in the past year). * No changes in asthma medications, oral corticosteroid use, or treatment for respiratory tract infections in the past week * Needs to have taken ≥ 3 courses of oral corticosteroids, for asthma, in the past 12 months. * Both male and female * English- or Spanish-speaking Exclusion Criteria: * Current substance or alcohol abuse/dependence * MDD with psychotic features (delusions, hallucinations, disorganized thought processes) * Bipolar disorder * Schizophrenia or schizoaffective disorder * Substance-induced mood disorder and mood disorder secondary to a general medical condition * Mental retardation or other severe cognitive impairment * Prison or jail inmates * Pregnant or nursing women or women of childbearing age who will not use The University of Texas Southwestern Medical Center - Institutional Review Board (UTSW IRB) approved methods of birth control or abstinence during the study * Treatment-resistant depressed persons defined as having failed two adequate trials of antidepressants * Current antipsychotic or antidepressant therapy or psychotherapy * Initiation of other psychotropic medications or psychotherapy within past 2 weeks (e.g., anxiolytics, hypnotics)
References
Publications (1)
- DERIVEDAgarwal CD, Palka JM, Gajewski AJ, Khan DA, Brown ES. The efficacy of citalopram or escitalopram in patients with asthma and major depressive disorder. Ann Allergy Asthma Immunol. 2024 Mar;132(3):374-382. doi: 10.1016/j.anai.2023.11.004. Epub 2023 Nov 11. PMID 37952772