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

Completed · Phase 4 · Has a placebo group

Conditions studied: Severe Asthma, Moderate or Severe Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00621946

Run by

University of Texas Southwestern Medical Center

People needed

26

Starts

2008-03-01

Expected to finish

2010-03-01

Last updated by the study team

2014-02-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• The UT Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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