Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00621946
First received: February 11, 2008
Last updated: January 2, 2014
Last verified: January 2014
Results First Received: May 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Severe Asthma
Moderate or Severe Major Depressive Disorder
Interventions: Drug: Placebo
Drug: Escitalopram

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Escitalopram 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.
Matching Placebo Placebo Matching Escitalopram taken orally daily (for a 12-week duration).

Participant Flow:   Overall Study
    Escitalopram     Matching Placebo  
STARTED     13     13  
COMPLETED     13     12  
NOT COMPLETED     0     1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One participant had no post-baseline data, leaving 25 evaluable participants in the intent-to-treat sample that was used in the analysis.

Reporting Groups
  Description
Escitalopram Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
Placebo Placebo Matching Escitalopram taken orally daily.
Total Total of all reporting groups

Baseline Measures
    Escitalopram     Placebo     Total  
Number of Participants  
[units: participants]
  13     12     25  
Age  
[units: years]
Mean ± Standard Deviation
  42.5  ± 9.8     48.6  ± 12.7     45.4  ± 11.5  
Gender  
[units: participants]
     
Female     8     6     14  
Male     5     6     11  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     6     4     10  
White     4     6     10  
More than one race     0     0     0  
Unknown or Not Reported     3     2     5  
Region of Enrollment  
[units: participants]
     
United States     13     12     25  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   HAM-D (Hamilton Rating Scale for Depression)   [ Time Frame: Baseline ]

2.  Primary:   ACQ (Asthma Control Questionnaire)   [ Time Frame: Baseline ]

3.  Primary:   IDS-SR (Inventory of Depressive Symptomatology - Self-Report)   [ Time Frame: Baseline ]

4.  Primary:   HAM-D (Hamilton Rating Scale for Depression)   [ Time Frame: Up to 12 weeks ]

5.  Primary:   ACQ (Asthma Control Questionnaire)   [ Time Frame: Up to 12 weeks ]

6.  Primary:   IDS-SR (Inventory of Depressive Symptomatology - Self-Report)   [ Time Frame: Up to 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
A limitation of this proof-of-concept study was the small sample size.


  More Information
  Hide More Information

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
e-mail: Sherwood.Brown@UTSouthwestern.edu


No publications provided


Responsible Party: Sherwood Brown, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00621946     History of Changes
Other Study ID Numbers: 092007-057
Study First Received: February 11, 2008
Results First Received: May 24, 2013
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board