Trial Outcomes & Findings for Effect of Amygdala Neurofeedback on Depressive Symptoms and Processing Biases (NCT NCT02079610)
NCT ID: NCT02079610
Last Updated: 2017-09-25
Results Overview
Depression symptom severity rating scale. The overall score ranges on MADRS are from from 0 to 60, with higher scores indicating more severe depression. Usual cutoff points are: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
baseline and 2 weeks
Results posted on
2017-09-25
Participant Flow
Participant milestones
| Measure |
Real-time fMRI Neurofeedback: Amygdala
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
|
Real-time fMRI Neurofeedback: HIPS
HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Real-time fMRI Neurofeedback: Amygdala
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
|
Real-time fMRI Neurofeedback: HIPS
HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Effect of Amygdala Neurofeedback on Depressive Symptoms and Processing Biases
Baseline characteristics by cohort
| Measure |
Real-time fMRI Neurofeedback: Amygdala
n=19 Participants
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
|
Real-time fMRI Neurofeedback: HIPS
n=17 Participants
HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 12 • n=5 Participants
|
31 years
STANDARD_DEVIATION 13 • n=7 Participants
|
31.6 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Count of participants
n=5 Participants
|
17 Count of participants
n=7 Participants
|
36 Count of participants
n=5 Participants
|
|
Montgomery-Asberg Depression Scale
|
23.5 units on a scale
STANDARD_DEVIATION 9.93 • n=5 Participants
|
23.8 units on a scale
STANDARD_DEVIATION 6.71 • n=7 Participants
|
23.61 units on a scale
STANDARD_DEVIATION 8.32 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 2 weeksPopulation: 1 participant in each group did not complete all study visits
Depression symptom severity rating scale. The overall score ranges on MADRS are from from 0 to 60, with higher scores indicating more severe depression. Usual cutoff points are: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression
Outcome measures
| Measure |
Real-time fMRI Neurofeedback: Amygdala
n=18 Participants
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
|
Real-time fMRI Neurofeedback: HIPS
n=16 Participants
HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
|
|---|---|---|
|
Change From Baseline in Montgomery Asberg Depression Rating Scale at 2 Weeks
MADRS absolute score at Baseline
|
23.5 units on a scale
Standard Deviation 9.93
|
23.8 units on a scale
Standard Deviation 6.71
|
|
Change From Baseline in Montgomery Asberg Depression Rating Scale at 2 Weeks
MADRS absolute score at Follow-Up
|
11.9 units on a scale
Standard Deviation 9.02
|
21.9 units on a scale
Standard Deviation 8.09
|
SECONDARY outcome
Timeframe: baseline and 2 weeksPopulation: One participant in each group did not complete all study visits
Depression symptom severity rating scale. The overall score ranges on BDI are from from 0 to 63, with higher scores indicating more severe depression. Usual cutoff points are: 0 to 13 - normal /symptom absent 14 to 19 - mild depression 20 to 28 - moderate depression \>29 - severe depression
Outcome measures
| Measure |
Real-time fMRI Neurofeedback: Amygdala
n=18 Participants
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
|
Real-time fMRI Neurofeedback: HIPS
n=16 Participants
HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
|
|---|---|---|
|
Change From Baseline Beck Depression Inventory at 2 Weeks
BDI absolute score at Baseline
|
27.2 units on a scale
Standard Deviation 10.7
|
26.6 units on a scale
Standard Deviation 13.4
|
|
Change From Baseline Beck Depression Inventory at 2 Weeks
BDI absolute score at Follow-up
|
16.1 units on a scale
Standard Deviation 9.66
|
24.3 units on a scale
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: baseline and 2 weeksPopulation: One participant in each group did not complete all study visits
Depression symptom severity rating scale. The overall score ranges on HDRS are from from 0 to 50, with higher scores indicating more severe depression. Usual cutoff points are: 0 to 7 - normal /symptom absent 8 to 16 - mild depression 17 to 23 - moderate depression \>24 - severe depression
Outcome measures
| Measure |
Real-time fMRI Neurofeedback: Amygdala
n=18 Participants
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
|
Real-time fMRI Neurofeedback: HIPS
n=16 Participants
HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
|
|---|---|---|
|
Change From Baseline Hamilton Rating Scale for Depression at 2 Weeks
HDRS absolute score at Baseline
|
19.4 units on a scale
Standard Deviation 7.87
|
19.1 units on a scale
Standard Deviation 4.39
|
|
Change From Baseline Hamilton Rating Scale for Depression at 2 Weeks
HDRS absolute score at Follow-up
|
10.4 units on a scale
Standard Deviation 7.06
|
17.2 units on a scale
Standard Deviation 4.99
|
Adverse Events
Real-time fMRI Neurofeedback: Amygdala
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Real-time fMRI Neurofeedback: HIPS
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
Kymberly Young, PhD
University of Pittsburgh School of Medicine
Phone: 412-648-6179
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place