Trial Outcomes & Findings for Antidepressant Treatment at an Inner City Asthma Clinic (NCT NCT01324700)
NCT ID: NCT01324700
Last Updated: 2018-05-22
Results Overview
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 (severely uncontrolled).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
139 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-05-22
Participant Flow
Participant milestones
| Measure |
High Severity: Escitalopram
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). To be assigned to the high severity group, participants had to have at least 3 steroid bursts in the past 12 months AND Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received escitalopram (or identical placebo) at the dose of 10 mg/day with follow-up visits every 2 weeks for 12 total weeks. Participants who had not shown a decrease in HRSD score of at least 30% by week 4, had their dosage of escitalopram increased to 20 mg/day (or equivalent placebo).
|
High Severity: Placebo
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). To be assigned to the high severity group, participants had to have at least 3 steroid bursts in the past 12 months AND Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received placebo (identical in appearance to the active medication) with follow-up visits every 2 weeks for 12 total weeks.
|
Low Severity: Escitalopram
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). To be assigned to the low severity group, participants had to have fewer than 3 steroid bursts in the past 12 months OR Hamilton Rating Scale for Depression (HRSD) score of less than 20 (or both). Participants received escitalopram (or identical placebo) at the dose of 10 mg/day with follow-up visits every 2 weeks for 12 total weeks. Participants who had not shown a decrease in HRSD score of at least 30% by week 4, had their dosage of escitalopram increased to 20 mg/day (or equivalent placebo).
|
Low Severity: Placebo
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). To be assigned to the low severity group, participants had to have fewer than 3 steroid bursts in the past 12 months OR Hamilton Rating Scale for Depression (HRSD) score of less than 20. Participants received placebo (identical in appearance to the active medication) with follow-up visits every 2 weeks for 12 total weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
49
|
48
|
|
Overall Study
COMPLETED
|
13
|
16
|
33
|
37
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
16
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antidepressant Treatment at an Inner City Asthma Clinic
Baseline characteristics by cohort
| Measure |
High Severity: Escitalopram
n=22 Participants
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants in the "high severity-escitalopram" group had at least 3 steroid bursts in the past 12 months AND Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received oral escitalopram at the dose of 10 mg/day with follow-up visits every 2 weeks for 12 total weeks. Participants who had not shown a decrease in HRSD score of at least 30% by week 4, had their dosage of escitalopram increased to 20 mg/day.
|
High Severity: Placebo
n=20 Participants
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants in the "high severity-placebo" group had at least 3 steroid bursts in the past 12 months AND Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received oral placebo (identical in appearance to the active medication) every 2 weeks for 12 total weeks.
|
Low Severity: Escitalopram
n=49 Participants
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants in the "low severity-escitalopram" group had at least 3 steroid bursts in the past 12 months OR Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received oral escitalopram at the dose of 10 mg/day with follow-up visits every 2 weeks for 12 total weeks. Participants who had not shown a decrease in HRSD score of at least 30% by week 4, had their dosage of escitalopram increased to 20 mg/day.
|
Low Severity: Placebo
n=48 Participants
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants in the "low severity-placebo" group had at least 3 steroid bursts in the past 12 months OR Hamilton Rating Scale for Depression (HRSD) score of at least 20. Participants received oral placebo (identical in appearance to the active medication) every 2 weeks for 12 total weeks.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.50 years
STANDARD_DEVIATION 12.34 • n=5 Participants
|
45.85 years
STANDARD_DEVIATION 11.17 • n=7 Participants
|
44.51 years
STANDARD_DEVIATION 12.08 • n=5 Participants
|
43.92 years
STANDARD_DEVIATION 11.60 • n=4 Participants
|
44.18 years
STANDARD_DEVIATION 11.74 • n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe 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 (severely uncontrolled).
Outcome measures
| Measure |
High Severity: Escitalopram
n=13 Participants
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
High Severity: Placebo
n=16 Participants
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
Low Severity: Escitalopram
n=33 Participants
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
Low Severity: Placebo
n=37 Participants
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
|---|---|---|---|---|
|
Asthma Control Questionnaire (ACQ)
|
1.15 units on a scale
Standard Deviation 0.48
|
1.63 units on a scale
Standard Deviation 0.89
|
1.39 units on a scale
Standard Deviation 0.20
|
1.23 units on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: 12 weeksThe patient is rated by a clinician on 17 items that measure depressive symptom severity. The total score is calculated by summing the responses across all items. Lower scores (closer to 0) indicate the absence of depressive symptoms, while higher scores indicate the presence of depressive symptoms. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2 (0 = not present; 2 = severe). The scale range of scores is 0-52.
Outcome measures
| Measure |
High Severity: Escitalopram
n=13 Participants
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
High Severity: Placebo
n=16 Participants
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
Low Severity: Escitalopram
n=33 Participants
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
Low Severity: Placebo
n=37 Participants
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
|---|---|---|---|---|
|
Hamilton Rating Scale for Depression (HRSD)
|
10.08 units on a scale
Standard Deviation 6.54
|
14.38 units on a scale
Standard Deviation 8.69
|
10.39 units on a scale
Standard Deviation 8.07
|
9.31 units on a scale
Standard Deviation 6.00
|
Adverse Events
High Severity: Escitalopram
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
High Severity: Placebo
Serious events: 8 serious events
Other events: 1 other events
Deaths: 0 deaths
Low Severity: Escitalopram
Serious events: 5 serious events
Other events: 5 other events
Deaths: 1 deaths
Low Severity: Placebo
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Severity: Escitalopram
n=22 participants at risk
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
High Severity: Placebo
n=20 participants at risk
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
Low Severity: Escitalopram
n=49 participants at risk
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
Low Severity: Placebo
n=48 participants at risk
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.5%
1/22
|
0.00%
0/20
|
0.00%
0/49
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
4.5%
1/22
|
0.00%
0/20
|
0.00%
0/49
|
0.00%
0/48
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/22
|
10.0%
2/20
|
0.00%
0/49
|
0.00%
0/48
|
|
Blood and lymphatic system disorders
Dehydration
|
0.00%
0/22
|
5.0%
1/20
|
0.00%
0/49
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
0.00%
0/22
|
15.0%
3/20
|
2.0%
1/49
|
6.2%
3/48
|
|
Cardiac disorders
Chest pain
|
0.00%
0/22
|
5.0%
1/20
|
0.00%
0/49
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/22
|
5.0%
1/20
|
0.00%
0/49
|
6.2%
3/48
|
|
Cardiac disorders
Hypertensive cardiovascular disease
|
0.00%
0/22
|
0.00%
0/20
|
2.0%
1/49
|
0.00%
0/48
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/22
|
0.00%
0/20
|
2.0%
1/49
|
0.00%
0/48
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/22
|
0.00%
0/20
|
2.0%
1/49
|
0.00%
0/48
|
|
Social circumstances
Fall
|
0.00%
0/22
|
0.00%
0/20
|
2.0%
1/49
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/49
|
2.1%
1/48
|
Other adverse events
| Measure |
High Severity: Escitalopram
n=22 participants at risk
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
High Severity: Placebo
n=20 participants at risk
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
Low Severity: Escitalopram
n=49 participants at risk
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
Low Severity: Placebo
n=48 participants at risk
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
13.6%
3/22
|
0.00%
0/20
|
2.0%
1/49
|
6.2%
3/48
|
|
Musculoskeletal and connective tissue disorders
Pain
|
4.5%
1/22
|
0.00%
0/20
|
0.00%
0/49
|
0.00%
0/48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Precancerous labial cells
|
0.00%
0/22
|
5.0%
1/20
|
0.00%
0/49
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/22
|
0.00%
0/20
|
2.0%
1/49
|
2.1%
1/48
|
|
Renal and urinary disorders
Kidney infection
|
0.00%
0/22
|
0.00%
0/20
|
2.0%
1/49
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/22
|
0.00%
0/20
|
2.0%
1/49
|
2.1%
1/48
|
|
Infections and infestations
Yeast infection
|
0.00%
0/22
|
0.00%
0/20
|
2.0%
1/49
|
0.00%
0/48
|
|
Gastrointestinal disorders
Acid reflux
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/49
|
2.1%
1/48
|
|
Vascular disorders
Fainting
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/49
|
2.1%
1/48
|
|
Vascular disorders
Dizziness
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/49
|
2.1%
1/48
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/49
|
2.1%
1/48
|
Additional Information
E. Sherwood Brown, MD, PhD, Professor of Psychiatry
University of Texas Southwestern Medical Center
Phone: 214-645-6950
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place