Trial Outcomes & Findings for fMRI Studies of Emotional Brain Circuitry in People With Major Depression (NCT NCT00749125)
NCT ID: NCT00749125
Last Updated: 2018-07-17
Results Overview
MRI scans from 41 participants (23 depressed and 18 controls), including fMRI scans using an emotional distractor task, were analyzed for differences between groups in activation in a priori regions (amygdala and DLPFC), measured with BOLD signal, for two conditions of the task - attend fearful and ignore fearful, both at baseline and following 8 weeks of treatment for the depressed group. Voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these regions. Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region. We expect more positive values (greater activation) in depressed participants at baseline than in controls during the attend fearful task, and more negative values (greater de-activation) in controls at baseline than depressed during the ignore fearful task. These differences were expected to lessen significantly following treatment in the depressed group.
COMPLETED
NA
99 participants
baseline and week 8
2018-07-17
Participant Flow
2004-2009. Participants from Washington University in St. Louis.
99 participants started the study and were assigned to either the depressed or control group.
Participant milestones
| Measure |
Control Participants
The nondepressed participants in this arm will not be given any intervention for depression.
At both the initial (baseline) and follow-up (8 weeks following baseline visit) study visits, images of brain function and anatomy will be recorded.
|
Depressed Participants
Following completion of their baseline study visit, the depressed participants will be given 8 weeks of antidepressant treatment as an intervention for depression.
At both the initial (baseline) and follow-up (post-intervention) study visits, images of brain function and anatomy will be recorded.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
52
|
|
Overall Study
COMPLETED
|
36
|
34
|
|
Overall Study
NOT COMPLETED
|
11
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nine of the 108 participants enrolled in the study either withdrew from the study or were withdrawn as no-shows prior to assignment to a group, and were not included in any analyses.
Baseline characteristics by cohort
| Measure |
1 Lexapro
n=52 Participants
The depressed participants in this arm will be given Lexapro.
Lexapro: 10 mg by mouth once per day for first 2 weeks, with psychiatric re-evaluation every 2 weeks to determine if any change in dosage is required, with a maximum of 20 mg per day.
At both the initial and follow-up fMRI (functional magnetic resonance imaging) study visits, images of brain function and anatomy will be recorded.
|
2 Control
n=47 Participants
The nondepressed participants in this arm will not be given any intervention for depression.
At both the initial and follow-up fMRI (functional magnetic resonance imaging) study visits, images of brain function and anatomy will be recorded.
|
Total
n=99 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
|
52 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
99 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
|
36.04 years
STANDARD_DEVIATION 9.605 • n=5 Participants • Nine of the 108 participants enrolled in the study either withdrew from the study or were withdrawn as no-shows prior to assignment to a group, and were not included in any analyses.
|
32.15 years
STANDARD_DEVIATION 8.228 • n=7 Participants • Nine of the 108 participants enrolled in the study either withdrew from the study or were withdrawn as no-shows prior to assignment to a group, and were not included in any analyses.
|
34.2 years
STANDARD_DEVIATION 9.1 • n=5 Participants • Nine of the 108 participants enrolled in the study either withdrew from the study or were withdrawn as no-shows prior to assignment to a group, and were not included in any analyses.
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
47 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and week 8Population: 23 patients with major depression were matched with 18 demographically similar healthy controls. Depressed subjects were treated with Lexapro 10 mg/day, initiated immediately following the first fMRI scan.
MRI scans from 41 participants (23 depressed and 18 controls), including fMRI scans using an emotional distractor task, were analyzed for differences between groups in activation in a priori regions (amygdala and DLPFC), measured with BOLD signal, for two conditions of the task - attend fearful and ignore fearful, both at baseline and following 8 weeks of treatment for the depressed group. Voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these regions. Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region. We expect more positive values (greater activation) in depressed participants at baseline than in controls during the attend fearful task, and more negative values (greater de-activation) in controls at baseline than depressed during the ignore fearful task. These differences were expected to lessen significantly following treatment in the depressed group.
Outcome measures
| Measure |
1 Lexapro
n=23 Participants
The depressed participants in this arm will be given Lexapro.
Lexapro: 10 mg by mouth once per day for first 2 weeks, with psychiatric re-evaluation every 2 weeks to determine if any change in dosage is required, with a maximum of 20 mg per day
|
2 Control
n=18 Participants
The nondepressed participants in this arm will not be given any intervention for depression.
|
|---|---|---|
|
Activations in Different Cortical Regions Caused by Emotionally Evocative Task
Baseline - Amygdala - attend fear
|
-0.021 Voxels
Standard Deviation 0.128
|
0.084 Voxels
Standard Deviation 0.135
|
|
Activations in Different Cortical Regions Caused by Emotionally Evocative Task
Baseline - Amygdala - ignore fear
|
0.021 Voxels
Standard Deviation 0.190
|
-0.030 Voxels
Standard Deviation 0.146
|
|
Activations in Different Cortical Regions Caused by Emotionally Evocative Task
Baseline - DLPFC - attend fear
|
0.072 Voxels
Standard Deviation 0.092
|
-0.025 Voxels
Standard Deviation 0.132
|
|
Activations in Different Cortical Regions Caused by Emotionally Evocative Task
Baseline - DLPFC - ignore fear
|
0.063 Voxels
Standard Deviation 0.129
|
0.073 Voxels
Standard Deviation 0.086
|
|
Activations in Different Cortical Regions Caused by Emotionally Evocative Task
Time 2 - Amygdala - attend fearful
|
-0.031 Voxels
Standard Deviation 0.264
|
-0.032 Voxels
Standard Deviation 0.178
|
|
Activations in Different Cortical Regions Caused by Emotionally Evocative Task
Time 2 - Amygdala - Ignore fearful
|
-0.031 Voxels
Standard Deviation .214
|
-0.041 Voxels
Standard Deviation 0.161
|
|
Activations in Different Cortical Regions Caused by Emotionally Evocative Task
Time 2 - DLPFC - Attend fearful
|
0.026 Voxels
Standard Deviation 0.134
|
0.075 Voxels
Standard Deviation 0.121
|
|
Activations in Different Cortical Regions Caused by Emotionally Evocative Task
Time 2 - DLPFC - Ignore fearful
|
0.091 Voxels
Standard Deviation 0.161
|
0.109 Voxels
Standard Deviation 0.123
|
Adverse Events
1 Lexapro
2 Control
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