Trial Outcomes & Findings for Study of Brain Response to Emotional Pictures Using a Magnetic Resonance Imaging (fMRI) While on Escitalopram (NCT NCT00707863)
NCT ID: NCT00707863
Last Updated: 2016-10-17
Results Overview
Standard scale for depression used in clinical trials. Range: 0 - 54. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate -severe depression.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2016-10-17
Participant Flow
Participant milestones
| Measure |
Depressed Subjects Age: 18 - 25 Yrs
Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks
|
Depressed Subjects Age: 16 - 50 Yrs
Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
11
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Brain Response to Emotional Pictures Using a Magnetic Resonance Imaging (fMRI) While on Escitalopram
Baseline characteristics by cohort
| Measure |
Depressed Subjects Age: 18 - 25 Yrs
n=6 Participants
Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks
|
Depressed Subjects Age: 16 - 50 Yrs
n=11 Participants
Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
22 years
STANDARD_DEVIATION 1 • n=5 Participants
|
34 years
STANDARD_DEVIATION 6 • n=7 Participants
|
30 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksStandard scale for depression used in clinical trials. Range: 0 - 54. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate -severe depression.
Outcome measures
| Measure |
Depressed Subjects Age: 18 - 25 Yrs
n=6 Participants
Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks
|
Depressed Subjects Age: 16 - 50 Yrs
n=8 Participants
Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks
|
|---|---|---|
|
17-item Hamilton Depression Rating Scale (HAM-D)
Baseline 17-item HAM-D
|
18 units on a scale
Standard Deviation 1
|
19 units on a scale
Standard Deviation 1
|
|
17-item Hamilton Depression Rating Scale (HAM-D)
Post-8 week treatment 17-item HAM-D
|
6 units on a scale
Standard Deviation 3
|
6 units on a scale
Standard Deviation 4
|
Adverse Events
Subjects Age: 18 - 25
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Subjects Age: 26 - 50
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects Age: 18 - 25
n=6 participants at risk
Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks
|
Subjects Age: 26 - 50
n=11 participants at risk
Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50
Escitalopram: 10 mg of Escitalopram by mouth per day for 8 weeks
|
|---|---|---|
|
Psychiatric disorders
Nervousness
|
16.7%
1/6
|
27.3%
3/11
|
|
Musculoskeletal and connective tissue disorders
Twitching
|
16.7%
1/6
|
27.3%
3/11
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6
|
27.3%
3/11
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6
|
18.2%
2/11
|
|
Gastrointestinal disorders
Diaarhea
|
16.7%
1/6
|
9.1%
1/11
|
|
Gastrointestinal disorders
Decreased appetite
|
66.7%
4/6
|
45.5%
5/11
|
|
Gastrointestinal disorders
Increased appetite
|
16.7%
1/6
|
9.1%
1/11
|
|
Nervous system disorders
Weakness or Fatigue
|
33.3%
2/6
|
27.3%
3/11
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6
|
36.4%
4/11
|
|
Cardiac disorders
Postural hypotension
|
33.3%
2/6
|
18.2%
2/11
|
|
Nervous system disorders
Drowsiness
|
50.0%
3/6
|
45.5%
5/11
|
|
Nervous system disorders
Increased sleep
|
66.7%
4/6
|
45.5%
5/11
|
|
Nervous system disorders
Decreased sleep
|
33.3%
2/6
|
54.5%
6/11
|
|
Skin and subcutaneous tissue disorders
Sweating
|
16.7%
1/6
|
45.5%
5/11
|
|
Cardiac disorders
Flushing
|
0.00%
0/6
|
9.1%
1/11
|
|
Cardiac disorders
Edema
|
0.00%
0/6
|
9.1%
1/11
|
|
Nervous system disorders
Headache
|
50.0%
3/6
|
45.5%
5/11
|
|
Eye disorders
Blurred vision
|
0.00%
0/6
|
18.2%
2/11
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6
|
63.6%
7/11
|
|
Reproductive system and breast disorders
Anorgasmia
|
33.3%
2/6
|
18.2%
2/11
|
|
Reproductive system and breast disorders
Increased libido
|
0.00%
0/6
|
0.00%
0/11
|
|
Reproductive system and breast disorders
decreased libido
|
33.3%
2/6
|
36.4%
4/11
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6
|
18.2%
2/11
|
|
Nervous system disorders
Tremor
|
0.00%
0/6
|
9.1%
1/11
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6
|
18.2%
2/11
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
36.4%
4/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place