Antidepressant Treatment at an Inner City Asthma Clinic
Condition: Depression; Asthma
MeSH terms: Asthma
Intervention: High severity group: Escitalopram; High severity group: Placebo; Low severity group: Escitalopram; Low severity group: Placebo
Intervention description: Participants within high severity group were stratified to receive escitalopram.; Participants within high severity group were stratified to receive placebo (inactive ingredient matching the active medication in appearance).; Participants within low severity group were stratified to receive escitalopram.; Participants within low severity group were stratified to receive placebo (inactive ingredient matching the active medication in appearance).
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram; Selective Serotonin Reuptake Inhibitors; Serotonin
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      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. Despite data on the frequency of depression in asthma
      and its adverse consequences, it is generally not recognized or treated. Brown et al.
      conducted a randomized, double-blind, placebo-controlled trial of citalopram in 90
      outpatients with asthma and MDD. Citalopram therapy was associated with lower depression
      scores, numerically greater rates of remission of depressive symptoms, and less oral
      corticosteroid use than placebo. The investigators proposed study is different. The
      investigators observed a modest difference between antidepressant and placebo in the 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) the investigators saw
      a much larger effect size. Standard of care for severe asthma is aggressive asthma treatment.
      The investigators 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute phase:

               -  Physician diagnosis of asthma and currently receiving asthma treatment, Current
                  diagnosis of MDD confirmed by the SCID and clinical assessment by a psychiatrist

               -  Baseline HRSD ≥ 15

               -  Baseline ACQ score of ≥ 1

               -  Ages 18-70 years to include the range of ages typically treated at our referral
                  sources

               -  No changes in asthma medications, oral corticosteroid use, or treatment for
                  respiratory tract infections in the past 2 weeks

               -  Both male and female

               -  English- or Spanish-speaking

          -  Continuation phase:

               -  Completed week 12 assessment of acute treatment phase

               -  Acute phase responders (defined as a baseline to week 12 reduction in the HRSD
                  score of 50% or greater)

        Exclusion Criteria:

          -  Acute phase:

               -  Current substance and alcohol abuse/dependence

               -  Current daily tobacco use

               -  Severe or life threatening medical illness that would make completion of study
                  unlikely (e.g. myocardial infarction)

               -  MDD with psychotic features (delusions, hallucinations, disorganized thought
                  processes, etc), bipolar disorder, schizophrenia, schizoaffective disorder, or
                  substance-induced mood disorder and mood disorders secondary to a general medical
                  condition

               -  Vulnerable populations including mentally retarded persons or those with 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

               -  Initiation on other psychotropic medications within the past 2 weeks

               -  High risk for suicide defined as > 1 past attempts or current suicidal ideation
                  with plan and intent or HRSD suicide question score of ≥ 2

               -  Use of antidepressants at therapeutic doses for depression within 1 week of study
                  entry. Potential participants taking antidepressants (other than escitalopram)
                  for depression may be enrolled following 1 week washout if they currently meet
                  depression entry criteria and have been taking the medication for at least 4
                  weeks at a therapeutic dose (non-responder)

               -  Patients currently taking but not responding to escitalopram (current study
                  drug). At week 8, if HRSD is < 25% decrease from HRSD baseline score, clinician
                  may consider discontinuation since response by week 12 in these patients is
                  unlikely

          -  Continuation phase:

               -  Development of exclusion criteria for acute phase (i.e., current suicidal
                  ideation with plan and intent)

               -  HRSD score > 50% of baseline score (no longer meets criteria as a responder)