Severe Asthma Clinical Trial
Official title:
Escitalopram in the Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial
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.
Primary Aim
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.
Secondary Aims
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
MDD.
Background/Significance
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
for asthma.
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
antidepressants.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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