Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder
Condition: Severe Asthma; Moderate or Severe Major Depressive Disorder
MeSH terms: Asthma; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Placebo; Escitalopram
Intervention type(s): Drug; Drug
Intervention description(s): Placebo Matching Escitalopram; Active Escitalopram
Other intervention name(s): Placebo Matching Escitalopram
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Depression; Escitalopram