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Trial record 53 of 585 for:    ESCITALOPRAM AND Celexa

Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder

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: NCT00621946
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : December 27, 2013
Last Update Posted : February 4, 2014
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Severe Asthma
Moderate or Severe Major Depressive Disorder
Interventions Drug: Placebo
Drug: Escitalopram
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Escitalopram Matching Placebo
Hide Arm/Group Description Once daily oral administration (for a 12-week duration) of 10 mg escitalopram tablets with an increase to 20 mg in those with a less than 30% decrease in HAM-D scores at week 4. Placebo Matching Escitalopram taken orally daily (for a 12-week duration).
Period Title: Overall Study
Started 13 13
Completed 13 12
Not Completed 0 1
Arm/Group Title Escitalopram Placebo Total
Hide Arm/Group Description Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily. Placebo Matching Escitalopram taken orally daily. Total of all reporting groups
Overall Number of Baseline Participants 13 12 25
Hide Baseline Analysis Population Description
One participant had no post-baseline data, leaving 25 evaluable participants in the intent-to-treat sample that was used in the analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 25 participants
42.5  (9.8) 48.6  (12.7) 45.4  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Female
8
  61.5%
6
  50.0%
14
  56.0%
Male
5
  38.5%
6
  50.0%
11
  44.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  46.2%
4
  33.3%
10
  40.0%
White
4
  30.8%
6
  50.0%
10
  40.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
  23.1%
2
  16.7%
5
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 12 participants 25 participants
13 12 25
1.Primary Outcome
Title HAM-D (Hamilton Rating Scale for Depression)
Hide Description The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
Placebo Matching Escitalopram taken orally daily.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
24.8  (4.4) 28.3  (5.1)
2.Primary Outcome
Title ACQ (Asthma Control Questionnaire)
Hide Description The ACQ is a questionnaire used to assess symptoms pertinent to asthma management. Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
Placebo Matching Escitalopram taken orally daily.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.9  (1.1) 2.9  (0.9)
3.Primary Outcome
Title IDS-SR (Inventory of Depressive Symptomatology - Self-Report)
Hide Description The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
Placebo Matching Escitalopram taken orally daily.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
35.2  (15.0) 42.9  (12.3)
4.Primary Outcome
Title HAM-D (Hamilton Rating Scale for Depression)
Hide Description The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Matching Placebo
Hide Arm/Group Description:
Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
Placebo Matching Escitalopram taken orally daily.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.7  (11.4) 17.7  (7.6)
5.Primary Outcome
Title ACQ (Asthma Control Questionnaire)
Hide Description The ACQ is a questionnaire used to assess symptoms pertinent to asthma management.Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Matching Placebo
Hide Arm/Group Description:
Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
Placebo Matching Escitalopram taken orally daily.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.9  (1.4) 2.4  (1.2)
6.Primary Outcome
Title IDS-SR (Inventory of Depressive Symptomatology - Self-Report)
Hide Description The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Matching Placebo
Hide Arm/Group Description:
Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
Placebo Matching Escitalopram taken orally daily.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
26.3  (17.4) 24.6  (14.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily. Placebo Matching Escitalopram taken orally daily.
All-Cause Mortality
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      1/12 (8.33%)    
Respiratory, thoracic and mediastinal disorders     
Severe asthma attack * [1]  1/13 (7.69%)  1 0/12 (0.00%)  0
Asthma exacerbation * [2]  1/13 (7.69%)  1 0/12 (0.00%)  0
Respiratory Infection * [3]  0/13 (0.00%)  0 1/12 (8.33%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Participant experienced a severe asthma attack, lost consciousness and was intubated at the intensive care unit. This event was serious, expected due to the patient's history, and not study-related. The patient was discontinued from the study.
[2]
This participant reported hospitalization for asthma exacerbation. This event was classified as serious, expected due to the patient's history, not study-related. The patient completed the study.
[3]
This participant was hospitalized for a worsening of asthma symptoms due to a viral respiratory infection that was successfully treated. This event was serious, unexpected, and not study-related. The patient was continued in the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Escitalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/12 (0.00%)    
A limitation of this proof-of-concept study was the small sample size.
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
Organization: The University of Texas Southwestern Medical Center
Phone: 214-645-6950
Responsible Party: Sherwood Brown, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00621946     History of Changes
Other Study ID Numbers: 092007-057
First Submitted: February 11, 2008
First Posted: February 22, 2008
Results First Submitted: May 24, 2013
Results First Posted: December 27, 2013
Last Update Posted: February 4, 2014