Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder
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ClinicalTrials.gov Identifier: NCT00621946 |
Recruitment Status :
Completed
First Posted : February 22, 2008
Results First Posted : December 27, 2013
Last Update Posted : February 4, 2014
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Condition or disease | Intervention/treatment | Phase |
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Severe Asthma Moderate or Severe Major Depressive Disorder | Drug: Placebo Drug: Escitalopram | Phase 4 |
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
- Determine if escitalopram treatment is associated with greater improvement in asthma symptoms than placebo in outpatients with severe asthma and moderate or severe MDD.
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | March 2008 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
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Placebo Comparator: Placebo
Placebo Matching Escitalopram given orally daily (for a 12-week duration).
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Drug: Placebo
Placebo Matching Escitalopram
Other Name: Placebo Matching Escitalopram |
Active Comparator: Escitalopram
Once daily oral administration (for a 12-week duration) of 10 mg escitalopram tablets with an increase to 20 mg in those with a less than 30% decrease in HAM-D scores at week 4.
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Drug: Escitalopram
Active Escitalopram |
- HAM-D (Hamilton Rating Scale for Depression) [ Time Frame: Baseline ]The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).
- ACQ (Asthma Control Questionnaire) [ Time Frame: Baseline ]The ACQ is a questionnaire used to assess symptoms pertinent to asthma management. Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).
- IDS-SR (Inventory of Depressive Symptomatology - Self-Report) [ Time Frame: Baseline ]The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).
- HAM-D (Hamilton Rating Scale for Depression) [ Time Frame: Up to 12 weeks ]The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).
- ACQ (Asthma Control Questionnaire) [ Time Frame: Up to 12 weeks ]The ACQ is a questionnaire used to assess symptoms pertinent to asthma management.Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).
- IDS-SR (Inventory of Depressive Symptomatology - Self-Report) [ Time Frame: Up to 12 weeks ]The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621946
United States, Texas | |
The UT Southwestern Medical Center at Dallas | |
Dallas, Texas, United States, 75390 |
Principal Investigator: | E. Sherwood Brown, Ph.D, M.D. | UT Southwestern Medical Center at Dallas |
Responsible Party: | Sherwood Brown, Principal Investigator, MD/PhD, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00621946 |
Other Study ID Numbers: |
092007-057 |
First Posted: | February 22, 2008 Key Record Dates |
Results First Posted: | December 27, 2013 |
Last Update Posted: | February 4, 2014 |
Last Verified: | January 2014 |
Asthma Depression Escitalopram |
Asthma Depressive Disorder Depression Depressive Disorder, Major Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Mood Disorders Mental Disorders Behavioral Symptoms |
Dexetimide Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics |