Trial Outcomes & Findings for Sinusitis and Facial Pain Disorders Anti-Depression Trial (NCT NCT00754793)
NCT ID: NCT00754793
Last Updated: 2014-01-17
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
baseline, 1 month, 3 months
Results posted on
2014-01-17
Participant Flow
Recruited patients with chronic sinusitis and depression (PHQ9\>=10) who were not already on an antidepressant.
No adverse events. No exclusions post enrollment.
Participant milestones
| Measure |
Active Drug (Lexapro)
escitalopram 10mg - 30mg daily
|
Placebo
Placebo drug
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Active Drug (Lexapro)
escitalopram 10mg - 30mg daily
|
Placebo
Placebo drug
|
|---|---|---|
|
Overall Study
voluntary withdrawn from study
|
0
|
1
|
Baseline Characteristics
Sinusitis and Facial Pain Disorders Anti-Depression Trial
Baseline characteristics by cohort
| Measure |
Active Drug (Lexapro)
n=1 Participants
escitalopram 10mg - 30mg daily
|
Placebo
n=2 Participants
Placebo drug
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 45 • n=93 Participants
|
50 years
STANDARD_DEVIATION 50 • n=4 Participants
|
48 years
STANDARD_DEVIATION 48 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline, 1 month, 3 monthsOutcome measures
Outcome data not reported
Adverse Events
Active Drug (Lexapro)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place