Antidepressant Treatment at an Inner City Asthma Clinic
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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 |
- 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: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Escitalopram |
Drug: Escitalopram
Escitalopram is an Antidepressant
Other Name: Lexipro, 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 |
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| Contact: Nasreen Sayed, MS | 214-645-6965 | nasreen.sayed@utsouthwestern.edu |
| Contact: Sherwood Brown, MD, PhD | 214-645-6950 | Sherwood.Brown@UTSouthwestern.edu |
| 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 | |
| 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: | April 17, 2013 |
| 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 June 18, 2013