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.
1) Determine if escitalopram treatment is associated with less oral corticosteroid use for
asthma symptom control than placebo in asthma outpatients with moderate or MDD.
1. Determine if escitalopram treatment is associated with greater improvement in asthma
symptoms than placebo in outpatients with severe asthma and moderate or severe MDD.
2. Determine if escitalopram treatment is associated with greater depressive symptom
remission rates than placebo in outpatients with severe asthma and moderate or severe
Asthma is a common, chronic general medical condition characterized by inflammation and
variable, but usually reversible, airflow obstruction. Approximately 7.2% of people in the
United States have a history of asthma. Asthma is common with an increasing prevalence and
mortality especially in low-income and minority populations.
The course of asthma appears to be influenced by mood and emotions. It has been reported
that there is a high prevalence of depression or depressive symptoms in both children and
adults with asthma.
Depression is associated with increased use of asthma-related urgent care services, as well
as a variety of unfavorable asthma outcomes. In addition to the possible associations
between depression and asthma medication nonadherence and even death, depression appears to
be associated with increased use of emergency rooms, hospitals, and unscheduled appointments
Despite data on the frequency of depression in asthma and its adverse consequences, it is
generally not recognized or treated.
Our proposed study is different. We observed a modest difference between antidepressant and
placebo in a prior trial. However, in a subgroup with more severe asthma (based on frequent
corticosteroid use) and more severe depression (based on higher depressive symptoms scores)
we saw a much larger effect size. The proposed study will target this subgroup. The sample
size is based on the effect size we observed in this subgroup in our previous pilot study.
A placebo controlled trial is needed because 1) the primary outcome in our previous trial
was not significant. Therefore, it is not clear that antidepressant treatment is effective
in depressed asthma patients. 2) We identified a subgroup with greater depressive symptom
and asthma severity that based on a post-hoc analysis appeared to show a favorable response
to the antidepressant. Thus, we want to confirm these post-hoc findings with a targeted
prospective study. In the clinical population we will study, very few patients have ever
received assessment or treatment for depression. Therefore, we would not be withholding
clearly effective treatment that they would otherwise receive.
Standard of care for severe asthma is aggressive asthma treatment. Our study does not
require any changes in the patient's asthma treatment. No guidelines are currently available
on the treatment of depression in asthma patients. Standard care for depression would be
- 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
- Both male and female
- English- or Spanish-speaking
- Current substance or alcohol abuse/dependence
- MDD with psychotic features (delusions, hallucinations, disorganized thought
- Bipolar disorder
- Schizophrenia or schizoaffective disorder
- Substance-induced mood disorder and mood disorder secondary to a general medical
- Mental retardation or other severe cognitive impairment
- Prison or jail inmates
- Pregnant or nursing women or women of childbearing age who will not use UTSW
IRB-approved methods of birth control or abstinence during the study
- Treatment-resistant depressed persons defined as having failed two adequate trials of
- Current antipsychotic or antidepressant therapy or psychotherapy
- Initiation of other psychotropic medications or psychotherapy within past 2 weeks
(e.g., anxiolytics, hypnotics)