Phase 4 N=26 Randomized Triple-blind Treatment

Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder

Severe Asthma · Moderate or Severe Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00621946 ↗

Enrolled (actual)

Serious AEs

12.0%

Results posted

Dec 2013

Primary outcome: Primary: HAM-D (Hamilton Rating Scale for Depression) — 24.8; 28.3 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Placebo (Drug); Escitalopram (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY HAM-D (Hamilton Rating Scale for Depression)	16.7; 17.7	—
PRIMARY ACQ (Asthma Control Questionnaire)	1.9; 2.4	—
PRIMARY IDS-SR (Inventory of Depressive Symptomatology - Self-Report)	26.3; 24.6	—
PRIMARY HAM-D (Hamilton Rating Scale for Depression)	16.7; 17.7	—
PRIMARY ACQ (Asthma Control Questionnaire)	1.9; 2.4	—
PRIMARY IDS-SR (Inventory of Depressive Symptomatology - Self-Report)	26.3; 24.6	—

Summary

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00621946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.