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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Forest Laboratories
• Treatments: Citalopram; Dexetimide

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)