Antidepressant Treatment at an Inner City Asthma Clinic

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01324700
First received: October 19, 2010
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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. Despite data on the frequency of depression in asthma and its adverse consequences, it is generally not recognized or treated. Brown et al. conducted a randomized, double-blind, placebo-controlled trial of citalopram in 90 outpatients with asthma and MDD. Citalopram therapy was associated with lower depression scores, numerically greater rates of remission of depressive symptoms, and less oral corticosteroid use than placebo. The investigators proposed study is different. The investigators observed a modest difference between antidepressant and placebo in the 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) the investigators saw a much larger effect size. Standard of care for severe asthma is aggressive asthma treatment. The investigators 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.


Condition Intervention Phase
Depression
Asthma
Drug: Escitalopram
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Antidepressant Treatment at an Inner City Asthma Clinic

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Asthma Control Questionnaire (ACQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The ACQ is a 7-item, self-report tool shown to be highly reliable and sensitive to changes in asthma symptomatology over time, assessing symptoms pertinent to asthma management identified by international guidelines including day and nighttime symptoms; activity limitation; use of prn bronchodilators; a physiological measure of asthma, forced expiratory volume in 1 second % predicted (FEV1% predicted); and the percentile of FEV1 compared to normal controls matched for age, height, gender, and race, in the scoring. Possible ranges of scores are from 0 to 42, divided by 7 (number of items).


Estimated Enrollment: 222
Study Start Date: July 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Escitalopram Drug: Escitalopram
Escitalopram is an Antidepressant
Other Name: Lexapro, Selective serotonin reuptake inhibitor (SSRI)
Placebo Comparator: Placebo Drug: Placebo
Inactive ingredient matching the active medication in appearance
Other Name: sugar pill

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute phase:

    • Physician diagnosis of asthma and currently receiving asthma treatment, Current diagnosis of MDD confirmed by the SCID and clinical assessment by a psychiatrist
    • Baseline HRSD ≥ 15
    • Baseline ACQ score of ≥ 1
    • Ages 18-70 years to include the range of ages typically treated at our referral sources
    • No changes in asthma medications, oral corticosteroid use, or treatment for respiratory tract infections in the past 2 weeks
    • Both male and female
    • English- or Spanish-speaking
  • Continuation phase:

    • Completed week 12 assessment of acute treatment phase
    • Acute phase responders (defined as a baseline to week 12 reduction in the HRSD score of 50% or greater)

Exclusion Criteria:

  • Acute phase:

    • Current substance and alcohol abuse/dependence
    • Current daily tobacco use
    • Severe or life threatening medical illness that would make completion of study unlikely (e.g. myocardial infarction)
    • MDD with psychotic features (delusions, hallucinations, disorganized thought processes, etc), bipolar disorder, schizophrenia, schizoaffective disorder, or substance-induced mood disorder and mood disorders secondary to a general medical condition
    • Vulnerable populations including mentally retarded persons or those with other severe cognitive impairment, prison or jail inmates, pregnant or nursing women or women of childbearing age who will not use UTSW IRB-approved methods of birth control or abstinence during the study
    • Initiation on other psychotropic medications within the past 2 weeks
    • High risk for suicide defined as > 1 past attempts or current suicidal ideation with plan and intent or HRSD suicide question score of ≥ 2
    • Use of antidepressants at therapeutic doses for depression within 1 week of study entry. Potential participants taking antidepressants (other than escitalopram) for depression may be enrolled following 1 week washout if they currently meet depression entry criteria and have been taking the medication for at least 4 weeks at a therapeutic dose (non-responder)
    • Patients currently taking but not responding to escitalopram (current study drug). At week 8, if HRSD is < 25% decrease from HRSD baseline score, clinician may consider discontinuation since response by week 12 in these patients is unlikely
  • Continuation phase:

    • Development of exclusion criteria for acute phase (i.e., current suicidal ideation with plan and intent)
    • HRSD score > 50% of baseline score (no longer meets criteria as a responder)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324700

Contacts
Contact: Nasreen Sayed, MS 214-645-6965 nasreen.sayed@utsouthwestern.edu
Contact: Sherwood Brown, MD, PhD 214-645-6950 Sherwood.Brown@UTSouthwestern.edu

Locations
United States, Texas
Parkland Health and Hospital System (Asthma, Allergy, & Arthritis Clinics) Recruiting
Dallas, Texas, United States, 75235
Contact: David Khan, MD    214-648-3004    David.Khan@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Sherwood Brown, MD, PhD UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01324700     History of Changes
Other Study ID Numbers: 072010-235, R18 HL092862
Study First Received: October 19, 2010
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Bronchial Diseases
Asthma
Depression
Depressive Disorder
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists

ClinicalTrials.gov processed this record on July 20, 2014