Trial Outcomes & Findings for Self-Control in Bulimia Nervosa (NCT NCT04409457)
NCT ID: NCT04409457
Last Updated: 2026-02-06
Results Overview
Frontostriatal activation modulated by the predicted need for inhibition (P(stop) (i.e., parametric modulation by p(Stop)), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases as the predicted probability of needing to stop increases (i.e., stronger responses when stopping is predicted to be more likely), whereas negative values indicate that activation decreases as the predicted probability of needing to stop increases (i.e., greater activation when stopping is predicted to be less likely).
COMPLETED
NA
100 participants
after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
2026-02-06
Participant Flow
100 individuals were recruited (from New York City and the surrounding community and the Center of Excellence in Eating and Weight Disorders at Mount Sinai) and signed informed consent for the full study.
Subjects completed several screening processes to determine eligibility.
Participant milestones
| Measure |
Participants With Bulimia Nervosa
Participants with Bulimia Nervosa who signed consent
|
Healthy Control Participants Without Bulimia Nervosa
Healthy Control Participants without Bulimia Nervosa who signed consent
|
Bulimia Nervosa Fast Then Fed
Participants were scanned after 16 hours of fasting (Fasted Scan) on one day, and were scanned after a standardized meal on a separate day (Fed Scan).
|
Bulimia Nervosa Fed Then Fast
Participants are scanned after a standardized meal on one day (Fed Scan) and are scanned after 16 hours of fasting (Fasted Scan) on a separate day,
|
Healthy Control Fast Then Fed
Participants are scanned after 16 hours of fasting (Fasted Scan) on one day, and are scanned after a standardized meal on a separate day (Fed Scan).
|
Healthy Control Fed Then Fast
Participants are scanned after a standardized meal on one day (Fed Scan) and are scanned after 16 hours of fasting (Fasted Scan) on a separate day,
|
|---|---|---|---|---|---|---|
|
Screening Prior to Randomization
STARTED
|
51
|
49
|
0
|
0
|
0
|
0
|
|
Screening Prior to Randomization
COMPLETED
|
33
|
35
|
0
|
0
|
0
|
0
|
|
Screening Prior to Randomization
NOT COMPLETED
|
18
|
14
|
0
|
0
|
0
|
0
|
|
Randomization
STARTED
|
0
|
0
|
16
|
17
|
18
|
17
|
|
Randomization
COMPLETED
|
0
|
0
|
16
|
16
|
17
|
15
|
|
Randomization
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Participants With Bulimia Nervosa
Participants with Bulimia Nervosa who signed consent
|
Healthy Control Participants Without Bulimia Nervosa
Healthy Control Participants without Bulimia Nervosa who signed consent
|
Bulimia Nervosa Fast Then Fed
Participants were scanned after 16 hours of fasting (Fasted Scan) on one day, and were scanned after a standardized meal on a separate day (Fed Scan).
|
Bulimia Nervosa Fed Then Fast
Participants are scanned after a standardized meal on one day (Fed Scan) and are scanned after 16 hours of fasting (Fasted Scan) on a separate day,
|
Healthy Control Fast Then Fed
Participants are scanned after 16 hours of fasting (Fasted Scan) on one day, and are scanned after a standardized meal on a separate day (Fed Scan).
|
Healthy Control Fed Then Fast
Participants are scanned after a standardized meal on one day (Fed Scan) and are scanned after 16 hours of fasting (Fasted Scan) on a separate day,
|
|---|---|---|---|---|---|---|
|
Screening Prior to Randomization
Screening fail prior to randomization
|
16
|
13
|
0
|
0
|
0
|
0
|
|
Screening Prior to Randomization
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Randomization
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Randomization
Incidental MRI finding at scan 1
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Randomization
Technical/equipment error at scan 1
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any binge eating.
Baseline characteristics by cohort
| Measure |
Participants With Bulimia Nervosa
n=32 Participants
Participants were scanned after 16 hours of fasting (Fasted Scan) on one day, and were scanned after a standardized meal on a separate day (Fed Scan). The order of these fasted and fed visits was counterbalanced across participants.
|
Healthy Control Participants Without Bulimia Nervosa
n=32 Participants
Participants were scanned after 16 hours of fasting (Fasted Scan) on one day, and were scanned after a standardized meal on a separate day (Fed Scan). The order of these fasted and fed visits was counterbalanced across participants.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.00 years
STANDARD_DEVIATION 4.64 • n=32 Participants
|
24.88 years
STANDARD_DEVIATION 3.65 • n=32 Participants
|
24.94 years
STANDARD_DEVIATION 4.14 • n=64 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=32 Participants
|
32 Participants
n=32 Participants
|
64 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=32 Participants
|
25 Participants
n=32 Participants
|
51 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=32 Participants
|
7 Participants
n=32 Participants
|
13 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=32 Participants
|
12 Participants
n=32 Participants
|
23 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=32 Participants
|
6 Participants
n=32 Participants
|
8 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=32 Participants
|
10 Participants
n=32 Participants
|
24 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=32 Participants
|
1 Participants
n=32 Participants
|
2 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=32 Participants
|
3 Participants
n=32 Participants
|
7 Participants
n=64 Participants
|
|
Number of objective binge eating episodes
Participants with Bulimia Nervosa
|
12.7 episodes in past 28 days
STANDARD_DEVIATION 11.4 • n=32 Participants • For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any binge eating.
|
—
|
12.7 episodes in past 28 days
STANDARD_DEVIATION 11.4 • n=32 Participants • For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any binge eating.
|
|
Number of objective binge eating episodes
Healthy Control
|
—
|
0 episodes in past 28 days
STANDARD_DEVIATION 0 • n=32 Participants • For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any binge eating.
|
0 episodes in past 28 days
STANDARD_DEVIATION 0 • n=32 Participants • For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any binge eating.
|
|
Number of self-induced vomiting episodes
Participants with Bulimia Nervosa
|
10.2 number of episodes in the past 28 days
STANDARD_DEVIATION 13.1 • n=32 Participants • For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any purging behaviors.
|
—
|
10.2 number of episodes in the past 28 days
STANDARD_DEVIATION 13.1 • n=32 Participants • For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any purging behaviors.
|
|
Number of self-induced vomiting episodes
Healthy Control
|
—
|
0 number of episodes in the past 28 days
STANDARD_DEVIATION 0 • n=32 Participants • For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any purging behaviors.
|
0 number of episodes in the past 28 days
STANDARD_DEVIATION 0 • n=32 Participants • For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any purging behaviors.
|
|
Number of fasting episodes
Participants with Bulimia Nervosa
|
8.69 number of episodes in the past 28 days
STANDARD_DEVIATION 7.75 • n=32 Participants • For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any fasting episodes.
|
—
|
8.69 number of episodes in the past 28 days
STANDARD_DEVIATION 7.75 • n=32 Participants • For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any fasting episodes.
|
|
Number of fasting episodes
Healthy Control
|
—
|
0 number of episodes in the past 28 days
STANDARD_DEVIATION 0 • n=32 Participants • For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any fasting episodes.
|
0 number of episodes in the past 28 days
STANDARD_DEVIATION 0 • n=32 Participants • For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any fasting episodes.
|
PRIMARY outcome
Timeframe: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)Population: Brain imaging data were pre-processed and analyzed for each group and state. Data from 8 participants were excluded: 2 HC due to technical malfunction that caused loss of behavioral data from their 2nd MRI visit, 1 HC for incidental finding on MRI (not identified until after their 2nd scan), 2 (1 BN, 1 HC) for insufficient trials for analysis in a key condition at one or both scans, and 3 BN for excessive movement (\>20% of TRs with ≥0.5mm framewise displacement) at one or both scans.
Frontostriatal activation modulated by the predicted need for inhibition (P(stop) (i.e., parametric modulation by p(Stop)), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases as the predicted probability of needing to stop increases (i.e., stronger responses when stopping is predicted to be more likely), whereas negative values indicate that activation decreases as the predicted probability of needing to stop increases (i.e., greater activation when stopping is predicted to be less likely).
Outcome measures
| Measure |
Participants With Bulimia Nervosa (Fasted Scan)
n=28 Participants
Participants are scanned after 16 hours of fasting (Fasted Scan)
|
Participants With Bulimia Nervosa (Fed Scan)
n=28 Participants
Participants are scanned after a standardized meal (Fed Scan).
|
Healthy Control Participants (Fasted Scan)
n=28 Participants
Participants are scanned after 16 hours of fasting (Fasted Scan)
|
Healthy Control Participants (Fed Scan)
n=28 Participants
Participants are scanned after a standardized meal (Fed Scan).
|
|---|---|---|---|---|
|
Brain Activation Associated With P(Stop)
Left Caudate Brain Activation
|
-0.16 BOLD Signal
Standard Deviation 0.36
|
-0.06 BOLD Signal
Standard Deviation 0.35
|
-0.05 BOLD Signal
Standard Deviation 0.31
|
-0.07 BOLD Signal
Standard Deviation 0.39
|
|
Brain Activation Associated With P(Stop)
Left Putamen Brain Activation
|
-0.06 BOLD Signal
Standard Deviation 0.28
|
-0.01 BOLD Signal
Standard Deviation 0.27
|
0.02 BOLD Signal
Standard Deviation 0.31
|
-0.01 BOLD Signal
Standard Deviation 0.29
|
|
Brain Activation Associated With P(Stop)
Left Dorsal ACC Activation
|
-0.07 BOLD Signal
Standard Deviation 0.27
|
0 BOLD Signal
Standard Deviation 0.29
|
-0.08 BOLD Signal
Standard Deviation 0.30
|
-0.06 BOLD Signal
Standard Deviation 0.31
|
|
Brain Activation Associated With P(Stop)
Left DLPFC Brain Activation
|
0.02 BOLD Signal
Standard Deviation 0.32
|
0.11 BOLD Signal
Standard Deviation 0.35
|
0.04 BOLD Signal
Standard Deviation 0.41
|
0.05 BOLD Signal
Standard Deviation 0.34
|
|
Brain Activation Associated With P(Stop)
Left VLPFC Brain Activation
|
0.01 BOLD Signal
Standard Deviation 0.28
|
0.03 BOLD Signal
Standard Deviation 0.29
|
-0.01 BOLD Signal
Standard Deviation 0.32
|
0.02 BOLD Signal
Standard Deviation 0.28
|
|
Brain Activation Associated With P(Stop)
Right DLPFC Brain Activation
|
0.07 BOLD Signal
Standard Deviation 0.36
|
0.14 BOLD Signal
Standard Deviation 0.37
|
0.14 BOLD Signal
Standard Deviation 0.36
|
0.12 BOLD Signal
Standard Deviation 0.34
|
|
Brain Activation Associated With P(Stop)
Right Caudate Brain Activation
|
-0.12 BOLD Signal
Standard Deviation 0.42
|
0 BOLD Signal
Standard Deviation 0.38
|
-0.02 BOLD Signal
Standard Deviation 0.32
|
-0.01 BOLD Signal
Standard Deviation 0.45
|
|
Brain Activation Associated With P(Stop)
Right Putamen Brain Activation
|
-0.05 BOLD Signal
Standard Deviation 0.31
|
-0.01 BOLD Signal
Standard Deviation 0.29
|
0.02 BOLD Signal
Standard Deviation 0.35
|
-0.01 BOLD Signal
Standard Deviation 0.30
|
|
Brain Activation Associated With P(Stop)
Right Dorsal ACC Activation
|
-0.07 BOLD Signal
Standard Deviation 0.25
|
0 BOLD Signal
Standard Deviation 0.23
|
-0.05 BOLD Signal
Standard Deviation 0.26
|
-0.04 BOLD Signal
Standard Deviation 0.29
|
|
Brain Activation Associated With P(Stop)
Right VLPFC Brain Activation
|
0.01 BOLD Signal
Standard Deviation 0.33
|
0.02 BOLD Signal
Standard Deviation 0.24
|
0.03 BOLD Signal
Standard Deviation 0.29
|
-0.01 BOLD Signal
Standard Deviation 0.27
|
PRIMARY outcome
Timeframe: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)Population: Brain imaging data were pre-processed and analyzed for each group and state. Data from 8 participants were excluded: 2 HC due to technical malfunction that caused loss of behavioral data from their 2nd MRI visit, 1 HC for incidental finding on MRI (not identified until after their 2nd scan), 2 (1 BN, 1 HC) for insufficient trials for analysis in a key condition at one or both scans, and 3 BN for excessive movement (\>20% of TRs with ≥0.5mm framewise displacement) at one or both scans.
Frontostriatal activation modulated by unsigned inhibitory control prediction errors (i.e., parametric modulation by absolute prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases with the magnitude of unsigned prediction errors (i.e., stronger responses to more surprising outcomes), whereas negative values indicate that activation decreases as unsigned prediction errors increase (i.e., relative deactivation for more surprising outcomes).
Outcome measures
| Measure |
Participants With Bulimia Nervosa (Fasted Scan)
n=28 Participants
Participants are scanned after 16 hours of fasting (Fasted Scan)
|
Participants With Bulimia Nervosa (Fed Scan)
n=28 Participants
Participants are scanned after a standardized meal (Fed Scan).
|
Healthy Control Participants (Fasted Scan)
n=28 Participants
Participants are scanned after 16 hours of fasting (Fasted Scan)
|
Healthy Control Participants (Fed Scan)
n=28 Participants
Participants are scanned after a standardized meal (Fed Scan).
|
|---|---|---|---|---|
|
Brain Activation Associated With Prediction Errors (Unsigned)
Right Putamen Brain Activation
|
0.13 BOLD Signal
Standard Deviation 0.31
|
0.08 BOLD Signal
Standard Deviation 0.28
|
0.14 BOLD Signal
Standard Deviation 0.35
|
0.07 BOLD Signal
Standard Deviation 0.35
|
|
Brain Activation Associated With Prediction Errors (Unsigned)
Left DLPFC Brain Activation
|
0.09 BOLD Signal
Standard Deviation 0.29
|
0.13 BOLD Signal
Standard Deviation 0.35
|
0.08 BOLD Signal
Standard Deviation 0.40
|
0.09 BOLD Signal
Standard Deviation 0.29
|
|
Brain Activation Associated With Prediction Errors (Unsigned)
Left Caudate Brain Activation
|
0.07 BOLD Signal
Standard Deviation 0.35
|
0.11 BOLD Signal
Standard Deviation 0.30
|
0.06 BOLD Signal
Standard Deviation 0.46
|
0.08 BOLD Signal
Standard Deviation 0.32
|
|
Brain Activation Associated With Prediction Errors (Unsigned)
Left Putamen Brain Activation
|
-0.03 BOLD Signal
Standard Deviation 0.26
|
-0.02 BOLD Signal
Standard Deviation 0.32
|
0.01 BOLD Signal
Standard Deviation 0.35
|
-0.06 BOLD Signal
Standard Deviation 0.39
|
|
Brain Activation Associated With Prediction Errors (Unsigned)
Left Dorsal ACC Activation
|
-0.02 BOLD Signal
Standard Deviation 0.32
|
0.07 BOLD Signal
Standard Deviation 0.29
|
0.09 BOLD Signal
Standard Deviation 0.41
|
-0.01 BOLD Signal
Standard Deviation 0.26
|
|
Brain Activation Associated With Prediction Errors (Unsigned)
Right Dorsal ACC Activation
|
0.05 BOLD Signal
Standard Deviation 0.28
|
0.10 BOLD Signal
Standard Deviation 0.25
|
0.09 BOLD Signal
Standard Deviation 0.35
|
0.01 BOLD Signal
Standard Deviation 0.24
|
|
Brain Activation Associated With Prediction Errors (Unsigned)
Left VLPFC Brain Activation
|
0.04 BOLD Signal
Standard Deviation 0.31
|
0.11 BOLD Signal
Standard Deviation 0.36
|
0.09 BOLD Signal
Standard Deviation 0.40
|
0.04 BOLD Signal
Standard Deviation 0.26
|
|
Brain Activation Associated With Prediction Errors (Unsigned)
Right VLPFC Brain Activation
|
0.29 BOLD Signal
Standard Deviation 0.26
|
0.28 BOLD Signal
Standard Deviation 0.23
|
0.45 BOLD Signal
Standard Deviation 0.30
|
0.34 BOLD Signal
Standard Deviation 0.30
|
|
Brain Activation Associated With Prediction Errors (Unsigned)
Right DLPFC Brain Activation
|
0.33 BOLD Signal
Standard Deviation 0.37
|
0.32 BOLD Signal
Standard Deviation 0.31
|
0.38 BOLD Signal
Standard Deviation 0.38
|
0.39 BOLD Signal
Standard Deviation 0.36
|
|
Brain Activation Associated With Prediction Errors (Unsigned)
Right Caudate Brain Activation
|
0.12 BOLD Signal
Standard Deviation 0.38
|
0.12 BOLD Signal
Standard Deviation 0.29
|
0.07 BOLD Signal
Standard Deviation 0.53
|
0.14 BOLD Signal
Standard Deviation 0.32
|
PRIMARY outcome
Timeframe: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)Population: Brain imaging data were pre-processed and analyzed for each group and state. Data from 8 participants were excluded: 2 HC due to technical malfunction that caused loss of behavioral data from their 2nd MRI visit, 1 HC for incidental finding on MRI (not identified until after their 2nd scan), 2 (1 BN, 1 HC) for insufficient trials for analysis in a key condition at one or both scans, and 3 BN for excessive movement (\>20% of TRs with ≥0.5mm framewise displacement) at one or both scans.
Frontostriatal activation modulated by signed inhibitory control prediction errors (i.e., parametric modulation by prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases as signed prediction errors become more positive (i.e., stronger responses to the surprising need for control), whereas negative values indicate that activation decreases as signed prediction errors become more positive (i.e., stronger responses to the surprising lack of need for control).
Outcome measures
| Measure |
Participants With Bulimia Nervosa (Fasted Scan)
n=28 Participants
Participants are scanned after 16 hours of fasting (Fasted Scan)
|
Participants With Bulimia Nervosa (Fed Scan)
n=28 Participants
Participants are scanned after a standardized meal (Fed Scan).
|
Healthy Control Participants (Fasted Scan)
n=28 Participants
Participants are scanned after 16 hours of fasting (Fasted Scan)
|
Healthy Control Participants (Fed Scan)
n=28 Participants
Participants are scanned after a standardized meal (Fed Scan).
|
|---|---|---|---|---|
|
Brain Activation Associated With Prediction Errors (Signed)
Left DLPFC Brain Activation
|
0.05 BOLD Signal
Standard Deviation 0.29
|
0.07 BOLD Signal
Standard Deviation 0.40
|
0.03 BOLD Signal
Standard Deviation 0.40
|
0.02 BOLD Signal
Standard Deviation 0.32
|
|
Brain Activation Associated With Prediction Errors (Signed)
Left Caudate Brain Activation
|
0.16 BOLD Signal
Standard Deviation 0.35
|
0.16 BOLD Signal
Standard Deviation 0.34
|
0.06 BOLD Signal
Standard Deviation 0.45
|
0.05 BOLD Signal
Standard Deviation 0.41
|
|
Brain Activation Associated With Prediction Errors (Signed)
Left Putamen Brain Activation
|
-0.04 BOLD Signal
Standard Deviation 0.25
|
-0.07 BOLD Signal
Standard Deviation 0.33
|
-0.07 BOLD Signal
Standard Deviation 0.34
|
-0.13 BOLD Signal
Standard Deviation 0.41
|
|
Brain Activation Associated With Prediction Errors (Signed)
Left Dorsal ACC Activation
|
0.03 BOLD Signal
Standard Deviation 0.36
|
0.09 BOLD Signal
Standard Deviation 0.36
|
0.10 BOLD Signal
Standard Deviation 0.43
|
-0.01 BOLD Signal
Standard Deviation 0.31
|
|
Brain Activation Associated With Prediction Errors (Signed)
Left VLPFC Brain Activation
|
0.02 BOLD Signal
Standard Deviation 0.33
|
0.10 BOLD Signal
Standard Deviation 0.41
|
0.07 BOLD Signal
Standard Deviation 0.39
|
0.03 BOLD Signal
Standard Deviation 0.26
|
|
Brain Activation Associated With Prediction Errors (Signed)
Right DLPFC Brain Activation
|
0.25 BOLD Signal
Standard Deviation 0.33
|
0.24 BOLD Signal
Standard Deviation 0.36
|
0.28 BOLD Signal
Standard Deviation 0.39
|
0.30 BOLD Signal
Standard Deviation 0.38
|
|
Brain Activation Associated With Prediction Errors (Signed)
Right Caudate Brain Activation
|
0.15 BOLD Signal
Standard Deviation 0.37
|
0.09 BOLD Signal
Standard Deviation 0.36
|
0.04 BOLD Signal
Standard Deviation 0.48
|
0.10 BOLD Signal
Standard Deviation 0.40
|
|
Brain Activation Associated With Prediction Errors (Signed)
Right Putamen Brain Activation
|
0.12 BOLD Signal
Standard Deviation 0.29
|
0.06 BOLD Signal
Standard Deviation 0.28
|
0.06 BOLD Signal
Standard Deviation 0.33
|
0.02 BOLD Signal
Standard Deviation 0.40
|
|
Brain Activation Associated With Prediction Errors (Signed)
Right Dorsal ACC Activation
|
0.09 BOLD Signal
Standard Deviation 0.31
|
0.11 BOLD Signal
Standard Deviation 0.32
|
0.11 BOLD Signal
Standard Deviation 0.36
|
0.02 BOLD Signal
Standard Deviation 0.28
|
|
Brain Activation Associated With Prediction Errors (Signed)
Right VLPFC Brain Activation
|
0.28 BOLD Signal
Standard Deviation 0.27
|
0.29 BOLD Signal
Standard Deviation 0.27
|
0.44 BOLD Signal
Standard Deviation 0.31
|
0.36 BOLD Signal
Standard Deviation 0.32
|
PRIMARY outcome
Timeframe: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)Population: Brain imaging data were pre-processed and analyzed for each group and state. Data from 8 participants were excluded: 2 HC due to technical malfunction that caused loss of behavioral data from their 2nd MRI visit, 1 HC for incidental finding on MRI (not identified until after their 2nd scan), 2 (1 BN, 1 HC) for insufficient trials for analysis in a key condition at one or both scans, and 3 BN for excessive movement (\>20% of TRs with ≥0.5mm framewise displacement) at one or both scans.
Frontostriatal activation associated with successful inhibition , measured as the mean BOLD signal across voxels within the region of interest (ROI) for the contrast of Successful Stop vs. Go trials. Positive values indicate activation associated with successful inhibition.
Outcome measures
| Measure |
Participants With Bulimia Nervosa (Fasted Scan)
n=28 Participants
Participants are scanned after 16 hours of fasting (Fasted Scan)
|
Participants With Bulimia Nervosa (Fed Scan)
n=28 Participants
Participants are scanned after a standardized meal (Fed Scan).
|
Healthy Control Participants (Fasted Scan)
n=28 Participants
Participants are scanned after 16 hours of fasting (Fasted Scan)
|
Healthy Control Participants (Fed Scan)
n=28 Participants
Participants are scanned after a standardized meal (Fed Scan).
|
|---|---|---|---|---|
|
Brain Activation Associated With Successful Inhibition
Right VLPFC Brain Activation
|
0.31 BOLD Signal
Standard Deviation 0.25
|
0.34 BOLD Signal
Standard Deviation 0.28
|
0.51 BOLD Signal
Standard Deviation 0.30
|
0.40 BOLD Signal
Standard Deviation 0.30
|
|
Brain Activation Associated With Successful Inhibition
Left Dorsal ACC Activation
|
-0.04 BOLD Signal
Standard Deviation 0.32
|
0.09 BOLD Signal
Standard Deviation 0.37
|
0.06 BOLD Signal
Standard Deviation 0.43
|
-0.04 BOLD Signal
Standard Deviation 0.28
|
|
Brain Activation Associated With Successful Inhibition
Left VLPFC Brain Activation
|
0.02 BOLD Signal
Standard Deviation 0.32
|
0.12 BOLD Signal
Standard Deviation 0.44
|
0.07 BOLD Signal
Standard Deviation 0.38
|
0.02 BOLD Signal
Standard Deviation 0.23
|
|
Brain Activation Associated With Successful Inhibition
Right Putamen Brain Activation
|
0.18 BOLD Signal
Standard Deviation 0.28
|
0.16 BOLD Signal
Standard Deviation 0.30
|
0.18 BOLD Signal
Standard Deviation 0.36
|
0.15 BOLD Signal
Standard Deviation 0.39
|
|
Brain Activation Associated With Successful Inhibition
Right Dorsal ACC Activation
|
0.03 BOLD Signal
Standard Deviation 0.27
|
0.13 BOLD Signal
Standard Deviation 0.32
|
0.09 BOLD Signal
Standard Deviation 0.36
|
0 BOLD Signal
Standard Deviation 0.25
|
|
Brain Activation Associated With Successful Inhibition
Left DLPFC Brain Activation
|
0.06 BOLD Signal
Standard Deviation 0.27
|
0.11 BOLD Signal
Standard Deviation 0.40
|
0.08 BOLD Signal
Standard Deviation 0.36
|
0.06 BOLD Signal
Standard Deviation 0.33
|
|
Brain Activation Associated With Successful Inhibition
Left Caudate Brain Activation
|
0.18 BOLD Signal
Standard Deviation 0.30
|
0.21 BOLD Signal
Standard Deviation 0.31
|
0.12 BOLD Signal
Standard Deviation 0.48
|
0.10 BOLD Signal
Standard Deviation 0.36
|
|
Brain Activation Associated With Successful Inhibition
Left Putamen Brain Activation
|
0.06 BOLD Signal
Standard Deviation 0.23
|
0.09 BOLD Signal
Standard Deviation 0.33
|
0.07 BOLD Signal
Standard Deviation 0.37
|
0.04 BOLD Signal
Standard Deviation 0.39
|
|
Brain Activation Associated With Successful Inhibition
Right DLPFC Brain Activation
|
0.29 BOLD Signal
Standard Deviation 0.32
|
0.32 BOLD Signal
Standard Deviation 0.38
|
0.43 BOLD Signal
Standard Deviation 0.37
|
0.39 BOLD Signal
Standard Deviation 0.38
|
|
Brain Activation Associated With Successful Inhibition
Right Caudate Brain Activation
|
0.22 BOLD Signal
Standard Deviation 0.34
|
0.16 BOLD Signal
Standard Deviation 0.32
|
0.15 BOLD Signal
Standard Deviation 0.52
|
0.19 BOLD Signal
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)Population: Brain imaging data were pre-processed and analyzed for each group and state. Data from 8 participants were excluded: 2 HC due to technical malfunction that caused loss of behavioral data from their 2nd MRI visit, 1 HC for incidental finding on MRI (not identified until after their 2nd scan), 2 (1 BN, 1 HC) for insufficient trials for analysis in a key condition at one or both scans, and 3 BN for excessive movement (\>20% of TRs with ≥0.5mm framewise displacement) at one or both scans.
Behavioral performance on the stop signal task, as measured by stop signal reaction time calculated as mean go reaction time minus the stop-signal delay at 50% successful inhibition (SSD₅₀). Higher SSRT means longer latency before failed inhibition.
Outcome measures
| Measure |
Participants With Bulimia Nervosa (Fasted Scan)
n=28 Participants
Participants are scanned after 16 hours of fasting (Fasted Scan)
|
Participants With Bulimia Nervosa (Fed Scan)
n=28 Participants
Participants are scanned after a standardized meal (Fed Scan).
|
Healthy Control Participants (Fasted Scan)
Participants are scanned after 16 hours of fasting (Fasted Scan)
|
Healthy Control Participants (Fed Scan)
Participants are scanned after a standardized meal (Fed Scan).
|
|---|---|---|---|---|
|
Stop Signal Reaction Time (SSRT)
Fasted Scan
|
164.37 Milliseconds
Standard Error 16.31
|
151.70 Milliseconds
Standard Error 18.89
|
—
|
—
|
|
Stop Signal Reaction Time (SSRT)
Fed Scan
|
170.80 Milliseconds
Standard Error 79.14
|
166.58 Milliseconds
Standard Error 13.99
|
—
|
—
|
SECONDARY outcome
Timeframe: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)Population: Brain imaging data were pre-processed and analyzed for each group and state. Data from 8 participants were excluded: 2 HC due to technical malfunction that caused loss of behavioral data from their 2nd MRI visit, 1 HC for incidental finding on MRI (not identified until after their 2nd scan), 2 (1 BN, 1 HC) for insufficient trials for analysis in a key condition at one or both scans, and 3 BN for excessive movement (\>20% of TRs with ≥0.5mm framewise displacement) at one or both scans.
Percent correct responses to stop trials on the Stop Signal Task measured by percent of stop trials on which participant successfully withheld a response (vs. failed to withhold response).
Outcome measures
| Measure |
Participants With Bulimia Nervosa (Fasted Scan)
n=28 Participants
Participants are scanned after 16 hours of fasting (Fasted Scan)
|
Participants With Bulimia Nervosa (Fed Scan)
n=28 Participants
Participants are scanned after a standardized meal (Fed Scan).
|
Healthy Control Participants (Fasted Scan)
Participants are scanned after 16 hours of fasting (Fasted Scan)
|
Healthy Control Participants (Fed Scan)
Participants are scanned after a standardized meal (Fed Scan).
|
|---|---|---|---|---|
|
Stop Signal Task Inhibition
Fasted Scan
|
57.29 percent correct responses
Standard Error 2.00
|
55.56 percent correct responses
Standard Error 2.62
|
—
|
—
|
|
Stop Signal Task Inhibition
Fed Scan
|
53.12 percent correct responses
Standard Error 3.05
|
56.25 percent correct responses
Standard Error 2.93
|
—
|
—
|
Adverse Events
Participants With Bulimia Nervosa
Healthy Control Participants Without Bulimia Nervosa
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants With Bulimia Nervosa
n=32 participants at risk
Participants were scanned after 16 hours of fasting (Fasted Scan) on one day, and were scanned after a standardized meal on a separate day (Fed Scan). The order of these fasted and fed visits was counterbalanced across participants.
|
Healthy Control Participants Without Bulimia Nervosa
n=32 participants at risk
Participants were scanned after 16 hours of fasting (Fasted Scan) on one day, and were scanned after a standardized meal on a separate day (Fed Scan). The order of these fasted and fed visits was counterbalanced across participants.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Reported Headache
|
0.00%
0/32 • At baseline clinical interviews, the 16-hour fasting period before scan visits, and at the two scan visits (up to 3 weeks on average)
|
6.2%
2/32 • At baseline clinical interviews, the 16-hour fasting period before scan visits, and at the two scan visits (up to 3 weeks on average)
|
|
Nervous system disorders
Potential structural abnormality identified on MRI
|
3.1%
1/32 • At baseline clinical interviews, the 16-hour fasting period before scan visits, and at the two scan visits (up to 3 weeks on average)
|
6.2%
2/32 • At baseline clinical interviews, the 16-hour fasting period before scan visits, and at the two scan visits (up to 3 weeks on average)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place