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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: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT01324700 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 139 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6
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 |
What the finished NCT01324700 record still lists
NCT01324700 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which High severity group: Escitalopram is the first listed.
NCT01324700 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01324700's enrollment target sits among peer trials
139 593rd of 2000 higher than 1,408 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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