Trial Outcomes & Findings for Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine (NCT NCT00532480)
NCT ID: NCT00532480
Last Updated: 2016-10-03
Results Overview
Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.
COMPLETED
PHASE4
10 participants
8 weeks
2016-10-03
Participant Flow
Participant milestones
| Measure |
Duloxetine
Duloxetine 60 mg capsules orally daily open label
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine
Baseline characteristics by cohort
| Measure |
Duloxetine
n=10 Participants
Duloxetine : 60 mg capsules
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 12 • n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: 10 patients included in the study out of which 7 completed 8 weeks of the study
Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.
Outcome measures
| Measure |
Duloxetine
n=7 Participants
Duloxetine : 60 mg capsules
|
|---|---|
|
17-item Hamilton Depression Rating Scale
Baseline 17-item HDRS
|
19 units on a scale
Standard Deviation 5
|
|
17-item Hamilton Depression Rating Scale
Post-treatment 17-item HDRS
|
10 units on a scale
Standard Deviation 5
|
Adverse Events
Duloxetine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Duloxetine
n=10 participants at risk
Duloxetine : 60 mg capsules
|
|---|---|
|
Nervous system disorders
decreased libido
|
40.0%
4/10 • Number of events 4 • 8 weeks
|
|
Nervous system disorders
headache
|
30.0%
3/10 • Number of events 3 • 8 weeks
|
|
Psychiatric disorders
Irritability
|
30.0%
3/10 • Number of events 3 • 8 weeks
|
|
Nervous system disorders
tremor
|
20.0%
2/10 • Number of events 2 • 8 weeks
|
|
Metabolism and nutrition disorders
increased appetite
|
20.0%
2/10 • Number of events 2 • 8 weeks
|
|
Psychiatric disorders
crying more often
|
10.0%
1/10 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
indigestion
|
10.0%
1/10 • Number of events 1 • 8 weeks
|
|
Psychiatric disorders
panic attack
|
10.0%
1/10 • Number of events 2 • 8 weeks
|
|
Nervous system disorders
sweating
|
10.0%
1/10 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
flushing
|
10.0%
1/10 • Number of events 1 • 8 weeks
|
|
Psychiatric disorders
nervousness
|
10.0%
1/10 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
no orgasm
|
10.0%
1/10 • Number of events 1 • 8 weeks
|
|
Psychiatric disorders
premature ejaculation
|
10.0%
1/10 • Number of events 1 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place