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Effect of Amygdala Neurofeedback on Depressive Symptoms and Processing Biases

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ClinicalTrials.gov Identifier: NCT02079610
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Laureate Institute for Brain Research, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Behavioral: real-time fMRI neurofeedback: Amygdala
Behavioral: real-time fMRI neurofeedback: HIPS
Enrollment 36

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Real-time fMRI Neurofeedback: Amygdala Real-time fMRI Neurofeedback: HIPS
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 19 17
Completed 18 16
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Real-time fMRI Neurofeedback: Amygdala Real-time fMRI Neurofeedback: HIPS Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 19 17 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 17 participants 36 participants
32  (12) 31  (13) 31.6  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
Female
13
  68.4%
13
  76.5%
26
  72.2%
Male
6
  31.6%
4
  23.5%
10
  27.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
Hispanic or Latino
1
   5.3%
0
   0.0%
1
   2.8%
Not Hispanic or Latino
18
  94.7%
17
 100.0%
35
  97.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.3%
1
   5.9%
2
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   5.9%
1
   2.8%
Black or African American
1
   5.3%
0
   0.0%
1
   2.8%
White
16
  84.2%
15
  88.2%
31
  86.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   5.3%
0
   0.0%
1
   2.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Count of participants
United States Number Analyzed 19 participants 17 participants 36 participants
19 17 36
Montgomery-Asberg Depression Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 19 participants 17 participants 36 participants
23.5  (9.93) 23.8  (6.71) 23.61  (8.32)
[1]
Measure Description:

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

1.Primary Outcome
Title Change From Baseline in Montgomery Asberg Depression Rating Scale at 2 Weeks
Hide Description

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

Time Frame baseline and 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 participant in each group did not complete all study visits
Arm/Group Title Real-time fMRI Neurofeedback: Amygdala Real-time fMRI Neurofeedback: HIPS
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
MADRS absolute score at Baseline 23.5  (9.93) 23.8  (6.71)
MADRS absolute score at Follow-Up 11.9  (9.02) 21.9  (8.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Real-time fMRI Neurofeedback: Amygdala, Real-time fMRI Neurofeedback: HIPS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10
Parameter Dispersion
Type: Standard Deviation
Value: 3.93
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline Beck Depression Inventory at 2 Weeks
Hide Description

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

Time Frame baseline and 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant in each group did not complete all study visits
Arm/Group Title Real-time fMRI Neurofeedback: Amygdala Real-time fMRI Neurofeedback: HIPS
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
BDI absolute score at Baseline 27.2  (10.7) 26.6  (13.4)
BDI absolute score at Follow-up 16.1  (9.66) 24.3  (12.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Real-time fMRI Neurofeedback: Amygdala, Real-time fMRI Neurofeedback: HIPS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.2
Parameter Dispersion
Type: Standard Deviation
Value: 5.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline Hamilton Rating Scale for Depression at 2 Weeks
Hide Description

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

Time Frame baseline and 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant in each group did not complete all study visits
Arm/Group Title Real-time fMRI Neurofeedback: Amygdala Real-time fMRI Neurofeedback: HIPS
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
HDRS absolute score at Baseline 19.4  (7.87) 19.1  (4.39)
HDRS absolute score at Follow-up 10.4  (7.06) 17.2  (4.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Real-time fMRI Neurofeedback: Amygdala, Real-time fMRI Neurofeedback: HIPS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.8
Parameter Dispersion
Type: Standard Deviation
Value: 3.5
Estimation Comments [Not Specified]
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Real-time fMRI Neurofeedback: Amygdala Real-time fMRI Neurofeedback: HIPS
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Real-time fMRI Neurofeedback: Amygdala Real-time fMRI Neurofeedback: HIPS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Real-time fMRI Neurofeedback: Amygdala Real-time fMRI Neurofeedback: HIPS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Real-time fMRI Neurofeedback: Amygdala Real-time fMRI Neurofeedback: HIPS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/17 (0.00%) 
large proportion of patients excluded primarily because of medication status or not meeting DSM-IV-TR criteria for major depressive disorder, limiting the generalizability Patients were only followed for 1 week after the final rtfMRI-nf session
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kymberly Young, PhD
Organization: University of Pittsburgh School of Medicine
Phone: 412-648-6179
Responsible Party: Laureate Institute for Brain Research, Inc.
ClinicalTrials.gov Identifier: NCT02079610     History of Changes
Other Study ID Numbers: 2013-013-00
4R00MH101235-03 ( U.S. NIH Grant/Contract )
First Submitted: March 4, 2014
First Posted: March 6, 2014
Results First Submitted: April 24, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017