Antidepressant Treatment at an Inner City Asthma Clinic
NCT01324700 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 139
Last updated 2018-05-22
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.
Conditions
Interventions
- DRUG
-
High severity group: Escitalopram
Participants within high severity group were stratified to receive escitalopram.
- DRUG
-
High severity group: Placebo
Participants within high severity group were stratified to receive placebo (inactive ingredient matching the active medication in appearance).
- DRUG
-
Low severity group: Escitalopram
Participants within low severity group were stratified to receive escitalopram.
- DRUG
-
Low severity group: Placebo
Participants within low severity group were stratified to receive placebo (inactive ingredient matching the active medication in appearance).
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
University of Texas Southwestern Medical Center
lead OTHER
Principal Investigators
-
Sherwood Brown, MD, PhD · UT Southwestern Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-07-31
- Primary Completion
- 2015-05-31
- Completion
- 2015-05-31
Countries
- United States
Study Locations
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