Trial Outcomes & Findings for An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa (NCT NCT00345943)
NCT ID: NCT00345943
Last Updated: 2021-12-02
Results Overview
This study will use magnetic resonance imaging (MRI) to assess the structure (cortical thickness) of neural circuit regions involved in Bulimia Nervosa (BN).
COMPLETED
71 participants
Baseline
2021-12-02
Participant Flow
Participant milestones
| Measure |
Adolescents With Bulimia Nervosa or Subclinical BN
Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests
|
Healthy Control Adolescents
Healthy control adolescents
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
33
|
|
Overall Study
COMPLETED
|
33
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group
Baseline characteristics by cohort
| Measure |
Adolescents With Bulimia Nervosa or Subclinical BN
n=33 Participants
Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests
|
Healthy Control Adolescents
n=28 Participants
Healthy control adolescents
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.5 years
STANDARD_DEVIATION 1.5 • n=33 Participants
|
16.2 years
STANDARD_DEVIATION 2.1 • n=28 Participants
|
16.4 years
STANDARD_DEVIATION 1.8 • n=61 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=33 Participants
|
28 Participants
n=28 Participants
|
61 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=33 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=33 Participants
|
9 Participants
n=28 Participants
|
20 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=33 Participants
|
19 Participants
n=28 Participants
|
41 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=33 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=33 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=33 Participants
|
5 Participants
n=28 Participants
|
9 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=33 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=33 Participants
|
5 Participants
n=28 Participants
|
6 Participants
n=61 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=33 Participants
|
18 Participants
n=28 Participants
|
46 Participants
n=61 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=33 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=33 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=61 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=33 Participants
|
28 participants
n=28 Participants
|
61 participants
n=61 Participants
|
|
Body Mass Index
|
22.1 kg/m^2
STANDARD_DEVIATION 2.8 • n=33 Participants
|
21.4 kg/m^2
STANDARD_DEVIATION 3.5 • n=28 Participants
|
21.8 kg/m^2
STANDARD_DEVIATION 3.1 • n=61 Participants
|
|
Wechsler Abbreviated Intelligence Scale (WASI)
|
105.5 units on a scale
STANDARD_DEVIATION 16.1 • n=33 Participants
|
104.9 units on a scale
STANDARD_DEVIATION 11.4 • n=28 Participants
|
105.2 units on a scale
STANDARD_DEVIATION 13.9 • n=61 Participants
|
|
Illness duration
|
26.0 months
STANDARD_DEVIATION 19.9 • n=33 Participants • This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group
|
—
|
26.0 months
STANDARD_DEVIATION 19.9 • n=33 Participants • This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group
|
|
Eating Disorder Examination - objective binge eating episodes (past 28 days)
|
13.8 Number of episodes
STANDARD_DEVIATION 17.8 • n=33 Participants • This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group
|
—
|
13.8 Number of episodes
STANDARD_DEVIATION 17.8 • n=33 Participants • This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group
|
|
Eating Disorder Examination - subjective binge eating episodes (past 28 days)
|
18.3 Number of episodes
STANDARD_DEVIATION 24.3 • n=33 Participants • This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group
|
—
|
18.3 Number of episodes
STANDARD_DEVIATION 24.3 • n=33 Participants • This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group
|
|
Eating Disorder Examination - self-induced vomiting episodes (past 28 days)
|
32.9 Number of episodes
STANDARD_DEVIATION 28.7 • n=33 Participants • This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group
|
—
|
32.9 Number of episodes
STANDARD_DEVIATION 28.7 • n=33 Participants • This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group
|
|
Eating Disorder Examination - loss of control episodes (past 28 days)
|
25.2 Number of episodes
STANDARD_DEVIATION 20.1 • n=33 Participants • This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group
|
—
|
25.2 Number of episodes
STANDARD_DEVIATION 20.1 • n=33 Participants • This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group
|
|
Comorbid Major Depressive Disorder
|
14 participants
n=33 Participants • Any lifetime Axis I disorder (including Major Depressive Disorder) was exclusionary for the Healthy control group
|
—
|
14 participants
n=33 Participants • Any lifetime Axis I disorder (including Major Depressive Disorder) was exclusionary for the Healthy control group
|
|
Comorbid Anxiety Disorders
|
7 participants
n=33 Participants • Any lifetime Axis I disorders (including Anxiety disorders) was exclusionary for the Healthy Control group
|
—
|
7 participants
n=33 Participants • Any lifetime Axis I disorders (including Anxiety disorders) was exclusionary for the Healthy Control group
|
|
Psychotropic Medication Use
|
9 participants
n=33 Participants • Psychotropic medication use was exclusionary for the Healthy Control group
|
—
|
9 participants
n=33 Participants • Psychotropic medication use was exclusionary for the Healthy Control group
|
|
Prior Anorexia Nervosa (%)
|
5 Participants
n=33 Participants • Any lifetime Axis I disorders (including Anorexia Nervosa) was exclusionary for the Healthy Control group
|
—
|
5 Participants
n=33 Participants • Any lifetime Axis I disorders (including Anorexia Nervosa) was exclusionary for the Healthy Control group
|
|
Inpatient Treatment
|
13 participants
n=33 Participants • Ongoing psychiatric treatment was exclusionary for the Healthy control group
|
—
|
13 participants
n=33 Participants • Ongoing psychiatric treatment was exclusionary for the Healthy control group
|
|
Outpatient Treatment
|
9 participants
n=33 Participants • Ongoing psychiatric treatment was exclusionary for the Healthy control group
|
—
|
9 participants
n=33 Participants • Ongoing psychiatric treatment was exclusionary for the Healthy control group
|
PRIMARY outcome
Timeframe: BaselineThis study will use magnetic resonance imaging (MRI) to assess the structure (cortical thickness) of neural circuit regions involved in Bulimia Nervosa (BN).
Outcome measures
| Measure |
Adolescents With Bulimia Nervosa or Subclinical BN
n=33 Participants
Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests
|
Healthy Control Adolescents
n=28 Participants
Healthy control adolescents
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests
|
|---|---|---|
|
Magnetic Resonance Imaging Scans
|
2.98 mm
Standard Deviation 0.22
|
2.96 mm
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: BaselineThe Conners Continuous Performance Test-II (CPT-II) is a standardized measure of attention and impulsivity. The following variables (T-scores) were used: Omissions: the number of times the participant failed to respond to a target. High T-score indicates a worse outcome. Commissions: the number of times the participant responded but no target was presented. High T-score indicates a worse outcome. Hit Reaction Time: time between the presentation of the stimulus and participant's response. A fast reaction time (low T-score) and high commission errors points to difficulties with impulsivity. A slow reaction time (high T-score) with high commission and omission errors, indicates inattention in general. Hit Reaction Time Standard Error: levels of inconsistency in response speed. High T-score indicates a worse outcome. Detectability: discrimination for target and nontarget. High T-score indicates a worse outcome. Population mean (standard deviation) = 50 (10)
Outcome measures
| Measure |
Adolescents With Bulimia Nervosa or Subclinical BN
n=30 Participants
Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests
|
Healthy Control Adolescents
n=23 Participants
Healthy control adolescents
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests
|
|---|---|---|
|
Conners Continuous Performance Test-II (CPT-II)
Omissions
|
49.52 T-scores
Standard Deviation 12.48
|
53.24 T-scores
Standard Deviation 16.50
|
|
Conners Continuous Performance Test-II (CPT-II)
Commissions
|
53.31 T-scores
Standard Deviation 8.25
|
50.20 T-scores
Standard Deviation 12.30
|
|
Conners Continuous Performance Test-II (CPT-II)
Hit Reaction Time
|
39.71 T-scores
Standard Deviation 7.33
|
45.57 T-scores
Standard Deviation 13.41
|
|
Conners Continuous Performance Test-II (CPT-II)
Hit Reaction Time Standard Error
|
45.81 T-scores
Standard Deviation 9.38
|
49.23 T-scores
Standard Deviation 11.06
|
|
Conners Continuous Performance Test-II (CPT-II)
Detectability
|
54.18 T-scores
Standard Deviation 6.47
|
50.98 T-scores
Standard Deviation 10.50
|
SECONDARY outcome
Timeframe: BaselineThe Stroop Word-Color Interference Test is a neuropsychological test assessing the ability to inhibit cognitive interference. The test contains three parts: word page (the names of colors printed in black ink), color page (rows of X's printed in colored ink) and word-color page (the words from the first page are printed in the colors from the second page; however, the word meanings and ink colors are mismatched).The subject's task is to look at each sheet and move down the columns, reading words or naming the ink colors as quickly as possible, within a given time limit (45 seconds). Three scores, as well as an interference score, are generated using the number of items completed on each page, with higher scores reflecting better performance and less interference on reading ability. Scores range 0-100.
Outcome measures
| Measure |
Adolescents With Bulimia Nervosa or Subclinical BN
n=33 Participants
Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests
|
Healthy Control Adolescents
n=28 Participants
Healthy control adolescents
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests
|
|---|---|---|
|
Stroop Word-Color Interference
|
22.1 score on a scale
Standard Deviation 6
|
21.5 score on a scale
Standard Deviation 5
|
SECONDARY outcome
Timeframe: BaselineThe Weather Prediction Task is a measure of probabilistic learning using experimental analysis of weather prediction. In this task, participants try to predict either "rain" or "shine" based on the presentation of cards whose cue-outcome associations vary probabilistically. Accuracy score (i.e. percentage of correct response) was used in our analyses. A higher score indicates better outcome. Values range 0-100%, with 50% being chance level.
Outcome measures
| Measure |
Adolescents With Bulimia Nervosa or Subclinical BN
n=19 Participants
Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests
|
Healthy Control Adolescents
n=20 Participants
Healthy control adolescents
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests
|
|---|---|---|
|
Weather Prediction Task
|
54.9 percentage of correct response
Standard Deviation 11.5
|
51.4 percentage of correct response
Standard Deviation 10.4
|
Adverse Events
Adolescents With Bulimia Nervosa or Subclinical BN
Healthy Control Adolescents
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