CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 139 enrolled
Drug / intervention
High severity group: Escitalopram +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01324700
NCT01324700Phase 4Completed

Antidepressant Treatment at an Inner City Asthma Clinic

University of Texas Southwestern Medical Center·interventional·Posted Mar 29, 2011·Updated May 22, 2018

In Brief

A Phase 4 clinical trial evaluating High severity group: Escitalopram, High severity group: Placebo, and 2 other interventions for Depression and Asthma. Completed, enrolled 139 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Asthma
CountriesUnited States

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2011
Enrollment StartJul 1, 2010
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 15.3 years ago

Interventions

High severity group: Escitalopramdrug

Participants within high severity group were stratified to receive escitalopram.

High severity group: Placebodrug

Participants within high severity group were stratified to receive placebo (inactive ingredient matching the active medication in appearance).

Low severity group: Escitalopramdrug

Participants within low severity group were stratified to receive escitalopram.

Low severity group: Placebodrug

Participants within low severity group were stratified to receive placebo (inactive ingredient matching the active medication in appearance).