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Trial record 82 of 531 for:    ESCITALOPRAM AND Disorders

Sinusitis and Facial Pain Disorders Anti-Depression Trial (SFPAT)

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: NCT00754793
Recruitment Status : Terminated (poor recruitment)
First Posted : September 18, 2008
Results First Posted : August 3, 2012
Last Update Posted : January 17, 2014
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Forest Laboratories
Information provided by (Responsible Party):
Greg Davis, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Chronic Sinusitis
Facial Pain Disorder
Depression
Interventions Drug: escitalopram
Drug: placebo
Enrollment 3
Recruitment Details Recruited patients with chronic sinusitis and depression (PHQ9>=10) who were not already on an antidepressant.
Pre-assignment Details No adverse events. No exclusions post enrollment.
Arm/Group Title Active Drug (Lexapro) Placebo
Hide Arm/Group Description escitalopram 10mg - 30mg daily Placebo drug
Period Title: Overall Study
Started 1 2
Completed 1 1
Not Completed 0 1
Reason Not Completed
voluntary withdrawn from study             0             1
Arm/Group Title Active Drug (Lexapro) Placebo Total
Hide Arm/Group Description escitalopram 10mg - 30mg daily Placebo drug Total of all reporting groups
Overall Number of Baseline Participants 1 2 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
  50.0%
2
  66.7%
>=65 years
0
   0.0%
1
  50.0%
1
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 2 participants 3 participants
45  (45) 50  (50) 48  (48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
Female
1
 100.0%
1
  50.0%
2
  66.7%
Male
0
   0.0%
1
  50.0%
1
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 2 participants 3 participants
1 2 3
1.Primary Outcome
Title Sino-Nasal Outcome Test-20 (SNOT-20)
Hide Description [Not Specified]
Time Frame baseline, 1 month, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Drug (Lexapro) Placebo
Hide Arm/Group Description:
escitalopram 10mg - 30mg daily
Placebo drug
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Drug (Lexapro) Placebo
Hide Arm/Group Description escitalopram 10mg - 30mg daily Placebo drug
All-Cause Mortality
Active Drug (Lexapro) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Drug (Lexapro) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Drug (Lexapro) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Greg E. Davis, MD MPH
Organization: University of Washington
Phone: 206-543-5230
Responsible Party: Greg Davis, University of Washington
ClinicalTrials.gov Identifier: NCT00754793     History of Changes
Other Study ID Numbers: 33501-B
1KL2RR025015-01 (NIH)
1KL2RR025015-01 ( U.S. NIH Grant/Contract )
First Submitted: September 16, 2008
First Posted: September 18, 2008
Results First Submitted: June 13, 2012
Results First Posted: August 3, 2012
Last Update Posted: January 17, 2014