Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00621946
First received: February 11, 2008
Last updated: January 2, 2014
Last verified: January 2014

February 11, 2008
January 2, 2014
March 2008
March 2010   (final data collection date for primary outcome measure)
  • HAM-D (Hamilton Rating Scale for Depression) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
Not Provided
Complete list of historical versions of study NCT00621946 on ClinicalTrials.gov Archive Site
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Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder
Escitalopram in the Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Severe Asthma
  • Moderate or Severe Major Depressive Disorder
  • Drug: Placebo
    Placebo Matching Escitalopram
    Other Name: Placebo Matching Escitalopram
  • Drug: Escitalopram
    Active Escitalopram
  • Placebo Comparator: Placebo
    Placebo Matching Escitalopram given orally daily (for a 12-week duration).
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
March 2010
March 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00621946
092007-057
Not Provided
Sherwood Brown, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Forest Laboratories
Principal Investigator: E. Sherwood Brown, Ph.D, M.D. UT Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP