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

NCT00621946 | Completed Phase 4 Results

• 1 other identifier: 092007-057
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Severe Asthma; Moderate or Severe Major Depressive Disorder

Keywords

Asthma; Depression; Escitalopram

Outcome Measures

Primary Outcomes (6)

• HAM-D (Hamilton Rating Scale for Depression)

  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).

  Baseline

• ACQ (Asthma Control Questionnaire)

  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).

  Baseline

• IDS-SR (Inventory of Depressive Symptomatology - Self-Report)

  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).

  Baseline

• HAM-D (Hamilton Rating Scale for Depression)

  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).

  Up to 12 weeks

• ACQ (Asthma Control Questionnaire)

  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).

  Up to 12 weeks

• IDS-SR (Inventory of Depressive Symptomatology - Self-Report)

  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).

  Up to 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo Matching Escitalopram given orally daily (for a 12-week duration).

Drug: Placebo

Escitalopram

ACTIVE COMPARATOR

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.

Drug: Escitalopram

Interventions

Placebo DRUG

Placebo Matching Escitalopram

Also known as: Placebo Matching Escitalopram

Placebo

Escitalopram DRUG

Active Escitalopram

Escitalopram

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Forest Laboratories: collaborator

Study Sites (1)

The UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Agarwal CD, Palka JM, Gajewski AJ, Khan DA, Brown ES. The efficacy of citalopram or escitalopram in patients with asthma and major depressive disorder. Ann Allergy Asthma Immunol. 2024 Mar;132(3):374-382. doi: 10.1016/j.anai.2023.11.004. Epub 2023 Nov 11.

  PMID: 37952772 DERIVED

MeSH Terms

Conditions

Asthma; Lymphoma, Follicular; Depressive Disorder, Major; Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

A limitation of this proof-of-concept study was the small sample size.

Results Point of Contact

• Title: E. Sherwood Brown, MD, PhD
• Organization: The University of Texas Southwestern Medical Center

Sherwood.Brown@UTSouthwestern.edu

214-645-6950

Study Officials

• E. Sherwood Brown, Ph.D, M.D.

  UT Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD/PhD

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 22, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 4, 2014
• Results First Posted: December 27, 2013

Record last verified: 2014-01

Locations

US (1)