Status:
COMPLETED
Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Forest Laboratories
Conditions:
Severe Asthma
Moderate or Severe Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 di...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00621946
Start Date
March 1 2008
End Date
March 1 2010
Last Update
February 4 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390