Antidepressant Treatment at an Inner City Asthma Clinic

Completed · Phase 4 · Has a placebo group

Conditions studied: Depression, Asthma

In brief

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.

Key facts

Study ID

NCT01324700

Run by

University of Texas Southwestern Medical Center

People needed

139

Starts

2010-07-01

Expected to finish

2015-05-01

Last updated by the study team

2018-05-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Parkland Health and Hospital System (Asthma, Allergy, & Arthritis Clinics) — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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