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NCT01324700 · ClinicalTrials.gov registry record · Phase 4
Antidepressant Treatment at an Inner City Asthma Clinic
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 139
- Enrollment target
NCT01324700 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 139 participants.
The verdict
NCT01324700, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 139 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG High severity group: Escitalopram
- DRUG High severity group: Placebo
- DRUG Low severity group: Escitalopram
- DRUG Low severity group: Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2010-07 |
| Est. Completion | 2015-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01324700
The ClinicalTrials.gov registry entry for NCT01324700 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which High severity group: Escitalopram is the first listed.
NCT01324700 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01324700 about?
NCT01324700 is a clinical study titled "Antidepressant Treatment at an Inner City Asthma Clinic". 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 wi...
What is the current status of trial NCT01324700?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 139 participants. The study started on 2010-07. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01324700?
The interventions under investigation include: High severity group: Escitalopram (DRUG), High severity group: Placebo (DRUG), Low severity group: Escitalopram (DRUG), Low severity group: Placebo (DRUG).
Who is sponsoring clinical trial NCT01324700?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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