Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 31 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

Antidepressant Treatment at an Inner City Asthma Clinic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01324700
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : February 16, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions Depression
Asthma
Interventions Drug: High severity group: Escitalopram
Drug: High severity group: Placebo
Drug: Low severity group: Escitalopram
Drug: Low severity group: Placebo
Enrollment 139
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Severity: Escitalopram High Severity: Placebo Low Severity: Escitalopram Low Severity: Placebo
Hide Arm/Group Description 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). 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. 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). 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.
Period Title: Overall Study
Started 22 20 49 48
Completed 13 16 33 37
Not Completed 9 4 16 11
Arm/Group Title High Severity: Escitalopram High Severity: Placebo Low Severity: Escitalopram Low Severity: Placebo Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 22 20 49 48 139
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 20 participants 49 participants 48 participants 139 participants
42.50  (12.34) 45.85  (11.17) 44.51  (12.08) 43.92  (11.60) 44.18  (11.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 49 participants 48 participants 139 participants
Female
17
  77.3%
13
  65.0%
39
  79.6%
31
  64.6%
100
  71.9%
Male
5
  22.7%
7
  35.0%
10
  20.4%
17
  35.4%
39
  28.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 49 participants 48 participants 139 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   2.0%
1
   2.1%
2
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  68.2%
11
  55.0%
29
  59.2%
28
  58.3%
83
  59.7%
White
6
  27.3%
9
  45.0%
19
  38.8%
19
  39.6%
53
  38.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   4.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.7%
1.Primary Outcome
Title Asthma Control Questionnaire (ACQ)
Hide Description 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).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Severity: Escitalopram High Severity: Placebo Low Severity: Escitalopram Low Severity: Placebo
Hide Arm/Group Description:
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
Overall Number of Participants Analyzed 13 16 33 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.15  (0.48) 1.63  (0.89) 1.39  (0.20) 1.23  (0.92)
2.Secondary Outcome
Title Hamilton Rating Scale for Depression (HRSD)
Hide Description The 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Severity: Escitalopram High Severity: Placebo Low Severity: Escitalopram Low Severity: Placebo
Hide Arm/Group Description:
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
Overall Number of Participants Analyzed 13 16 33 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.08  (6.54) 14.38  (8.69) 10.39  (8.07) 9.31  (6.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Severity: Escitalopram High Severity: Placebo Low Severity: Escitalopram Low Severity: Placebo
Hide Arm/Group Description Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description). Participants were stratified into high vs. low severity groups, and then further stratified into escitalopram or placebo groups (see study arm/intervention description).
All-Cause Mortality
High Severity: Escitalopram High Severity: Placebo Low Severity: Escitalopram Low Severity: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/20 (0.00%)   1/49 (2.04%)   0/48 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
High Severity: Escitalopram High Severity: Placebo Low Severity: Escitalopram Low Severity: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/22 (9.09%)   8/20 (40.00%)   5/49 (10.20%)   7/48 (14.58%) 
Blood and lymphatic system disorders         
Dehydration   0/22 (0.00%)  1/20 (5.00%)  0/49 (0.00%)  0/48 (0.00%) 
Cardiac disorders         
Congestive heart failure   0/22 (0.00%)  2/20 (10.00%)  0/49 (0.00%)  0/48 (0.00%) 
Chest pain   0/22 (0.00%)  1/20 (5.00%)  0/49 (0.00%)  0/48 (0.00%) 
Hypertensive cardiovascular disease   0/22 (0.00%)  0/20 (0.00%)  1/49 (2.04%)  0/48 (0.00%) 
Metabolism and nutrition disorders         
Hypoglycemia   1/22 (4.55%)  0/20 (0.00%)  0/49 (0.00%)  0/48 (0.00%) 
Diabetic ketoacidosis   0/22 (0.00%)  0/20 (0.00%)  1/49 (2.04%)  0/48 (0.00%) 
Musculoskeletal and connective tissue disorders         
Pain   0/22 (0.00%)  0/20 (0.00%)  1/49 (2.04%)  0/48 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma exacerbation   0/22 (0.00%)  3/20 (15.00%)  1/49 (2.04%)  3/48 (6.25%) 
Pneumonia   0/22 (0.00%)  1/20 (5.00%)  0/49 (0.00%)  3/48 (6.25%) 
Sinusitis   0/22 (0.00%)  0/20 (0.00%)  0/49 (0.00%)  1/48 (2.08%) 
Skin and subcutaneous tissue disorders         
Cellulitis   1/22 (4.55%)  0/20 (0.00%)  0/49 (0.00%)  0/48 (0.00%) 
Social circumstances         
Fall   0/22 (0.00%)  0/20 (0.00%)  1/49 (2.04%)  0/48 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
High Severity: Escitalopram High Severity: Placebo Low Severity: Escitalopram Low Severity: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/22 (18.18%)   1/20 (5.00%)   5/49 (10.20%)   9/48 (18.75%) 
Gastrointestinal disorders         
Acid reflux   0/22 (0.00%)  0/20 (0.00%)  0/49 (0.00%)  1/48 (2.08%) 
Infections and infestations         
Yeast infection   0/22 (0.00%)  0/20 (0.00%)  1/49 (2.04%)  0/48 (0.00%) 
Musculoskeletal and connective tissue disorders         
Pain   1/22 (4.55%)  0/20 (0.00%)  0/49 (0.00%)  0/48 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Precancerous labial cells   0/22 (0.00%)  1/20 (5.00%)  0/49 (0.00%)  0/48 (0.00%) 
Renal and urinary disorders         
Kidney infection   0/22 (0.00%)  0/20 (0.00%)  1/49 (2.04%)  0/48 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma exacerbation   3/22 (13.64%)  0/20 (0.00%)  1/49 (2.04%)  3/48 (6.25%) 
Upper respiratory infection   0/22 (0.00%)  0/20 (0.00%)  1/49 (2.04%)  1/48 (2.08%) 
Bronchitis   0/22 (0.00%)  0/20 (0.00%)  1/49 (2.04%)  1/48 (2.08%) 
Skin and subcutaneous tissue disorders         
Rash   0/22 (0.00%)  0/20 (0.00%)  0/49 (0.00%)  1/48 (2.08%) 
Vascular disorders         
Fainting   0/22 (0.00%)  0/20 (0.00%)  0/49 (0.00%)  1/48 (2.08%) 
Dizziness   0/22 (0.00%)  0/20 (0.00%)  0/49 (0.00%)  1/48 (2.08%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: E. Sherwood Brown, MD, PhD, Professor of Psychiatry
Organization: University of Texas Southwestern Medical Center
Phone: 214-645-6950
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01324700     History of Changes
Other Study ID Numbers: 072010-235
R18HL092862 ( U.S. NIH Grant/Contract )
First Submitted: October 19, 2010
First Posted: March 29, 2011
Results First Submitted: October 17, 2017
Results First Posted: February 16, 2018
Last Update Posted: May 22, 2018