Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder
Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Severe Asthma; Moderate or Severe Major Depressive Disorder
Intervention: Placebo (Drug); Escitalopram (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s): E. Sherwood Brown, Ph.D, M.D., Principal Investigator, Affiliation: UT Southwestern Medical Center at Dallas
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.
Clinical Details
Official title: Escitalopram in the Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: HAM-D (Hamilton Rating Scale for Depression)ACQ (Asthma Control Questionnaire) IDS-SR (Inventory of Depressive Symptomatology - Self-Report) HAM-D (Hamilton Rating Scale for Depression) ACQ (Asthma Control Questionnaire) IDS-SR (Inventory of Depressive Symptomatology - Self-Report)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Current HAM-D score of ≥ 20
- Patients with severe asthma (defined as asthma requiring three or more course of oral
corticosteroids in the past year).
- No changes in asthma medications, oral corticosteroid use, or treatment for
respiratory tract infections in the past week
- Needs to have taken ≥ 3 courses of oral corticosteroids, for asthma, in the past 12
months.
- Both male and female
- English- or Spanish-speaking
Exclusion Criteria:
- Current substance or alcohol abuse/dependence
- MDD with psychotic features (delusions, hallucinations, disorganized thought
processes)
- Bipolar disorder
- Schizophrenia or schizoaffective disorder
- Substance-induced mood disorder and mood disorder secondary to a general medical
condition
- Mental retardation or other severe cognitive impairment
- Prison or jail inmates
- Pregnant or nursing women or women of childbearing age who will not use The
University of Texas Southwestern Medical Center - Institutional Review Board (UTSW
IRB) approved methods of birth control or abstinence during the study
- Treatment-resistant depressed persons defined as having failed two adequate trials of
antidepressants
- Current antipsychotic or antidepressant therapy or psychotherapy
- Initiation of other psychotropic medications or psychotherapy within past 2 weeks
(e. g., anxiolytics, hypnotics)
Locations and Contacts
The UT Southwestern Medical Center at Dallas, Dallas, Texas 75390, United States
Additional Information
Starting date: March 2008
Last updated: January 2, 2014
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