Eating Disorders
Conditions
Keywords
Eating Disorders, Bulimia Nervosa, Bulimia, fMRI, Magnetic Resonance Imaging
Brief summary
The aim of this project is to use both multimodal MRI and behavioral measures to investigate how changes in frontostriatal neural systems contribute to the development and persistence of Bulimia Nervosa (BN). Findings from this study will have wide-ranging importance for our understanding of the development and treatment of BN.
Detailed description
Patients with Bulimia Nervosa (BN) have difficulty regulating impulsive behaviors as suggested by their binge-eating and purging, as well as the high incidence of drug abuse and shoplifting in this population. Understanding dysfunction in the frontostriatal circuitry that mediates self-regulatory control processes will aid development of new therapeutics for the impulsivity associated with BN. We are conducting a longitudinal study to better understand the development and persistence of BN. Participation in this study includes 4 sections: Neuropsychological Tests, Diagnostic interviews, Pregnancy Test, and MRI scan. All efforts are made to coordinate procedures into one day, and they require between 4 and 5 hours of the participant's time. The option of splitting participation into two study days is also offered for participants who find it more convenient. Participants are compensated with $100 in the form of a check, which is mailed to their home address. Participants will be invited back for follow-up visits.
Interventions
OTHERMRI
Magnetic Resonance Imaging scans
BEHAVIORALNeuropsychological Testing
Neuropsychological tests
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Current or prior DSM IV diagnosis of Bulimia Nervosa or Sub-threshold Bulimia Nervosa (those who meet all DSM-IV criteria for BN, but engage in subjective binge-eating episodes and binge/purge at a frequency of at least once per week for 3 months, whereas meeting full DSM-IV criteria for BN requires binge eating and purging twice per week for 3 months) * Major Depression * For control adolescents, no current or past history of an eating disorder
Exclusion criteria
* Ferromagnetic implants (e.g., pacemaker) * Metal braces or retainers * IQ less than 80 * Any other current major Axis I disorder, other than major depressive disorder (MDD) * History of concussion, seizure disorder, or other neurological illness * Claustrophobia * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnetic Resonance Imaging Scans | Baseline | This study will use magnetic resonance imaging (MRI) to assess the structure (cortical thickness) of neural circuit regions involved in Bulimia Nervosa (BN). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conners Continuous Performance Test-II (CPT-II) | Baseline | The 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) |
| Stroop Word-Color Interference | Baseline | The 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. |
| Weather Prediction Task | Baseline | The 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adolescents With Bulimia Nervosa or Subclinical BN Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests | 33 |
| Healthy Control Adolescents Healthy control adolescents
MRI: Magnetic Resonance Imaging scans
Neuropsychological Testing: Neuropsychological tests | 28 |
| Total | 61 |
Baseline characteristics
| Characteristic | Adolescents With Bulimia Nervosa or Subclinical BN | Total | Healthy Control Adolescents |
|---|---|---|---|
| Age, Continuous | 16.5 years STANDARD_DEVIATION 1.5 | 16.4 years STANDARD_DEVIATION 1.8 | 16.2 years STANDARD_DEVIATION 2.1 |
| Body Mass Index | 22.1 kg/m^2 STANDARD_DEVIATION 2.8 | 21.8 kg/m^2 STANDARD_DEVIATION 3.1 | 21.4 kg/m^2 STANDARD_DEVIATION 3.5 |
| Comorbid Anxiety Disorders | 7 participants | 7 participants | — |
| Comorbid Major Depressive Disorder | 14 participants | 14 participants | — |
| Eating Disorder Examination - loss of control episodes (past 28 days) | 25.2 Number of episodes STANDARD_DEVIATION 20.1 | 25.2 Number of episodes STANDARD_DEVIATION 20.1 | — |
| Eating Disorder Examination - objective binge eating episodes (past 28 days) | 13.8 Number of episodes STANDARD_DEVIATION 17.8 | 13.8 Number of episodes STANDARD_DEVIATION 17.8 | — |
| Eating Disorder Examination - self-induced vomiting episodes (past 28 days) | 32.9 Number of episodes STANDARD_DEVIATION 28.7 | 32.9 Number of episodes STANDARD_DEVIATION 28.7 | — |
| Eating Disorder Examination - subjective binge eating episodes (past 28 days) | 18.3 Number of episodes STANDARD_DEVIATION 24.3 | 18.3 Number of episodes STANDARD_DEVIATION 24.3 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 20 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 41 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Illness duration | 26.0 months STANDARD_DEVIATION 19.9 | 26.0 months STANDARD_DEVIATION 19.9 | — |
| Inpatient Treatment | 13 participants | 13 participants | — |
| Outpatient Treatment | 9 participants | 9 participants | — |
| Prior Anorexia Nervosa (%) | 5 Participants | 5 Participants | — |
| Psychotropic Medication Use | 9 participants | 9 participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 46 Participants | 18 Participants |
| Region of Enrollment United States | 33 participants | 61 participants | 28 participants |
| Sex: Female, Male Female | 33 Participants | 61 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Wechsler Abbreviated Intelligence Scale (WASI) | 105.5 units on a scale STANDARD_DEVIATION 16.1 | 105.2 units on a scale STANDARD_DEVIATION 13.9 | 104.9 units on a scale STANDARD_DEVIATION 11.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 33 |
| other Total, other adverse events | 0 / 38 | 0 / 33 |
| serious Total, serious adverse events | 0 / 38 | 0 / 33 |
Outcome results
Primary
Magnetic Resonance Imaging Scans
This study will use magnetic resonance imaging (MRI) to assess the structure (cortical thickness) of neural circuit regions involved in Bulimia Nervosa (BN).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescents With Bulimia Nervosa or Subclinical BN | Magnetic Resonance Imaging Scans | 2.98 mm | Standard Deviation 0.22 |
| Healthy Control Adolescents | Magnetic Resonance Imaging Scans | 2.96 mm | Standard Deviation 0.22 |
Comparison: Growth curve models examined the following: group (BN versus HC) differences in cortical thickness (CT) at baseline; group differences in the rate of change in CT over time; and the persistence of group differences in CT over time.p-value: 0.03Mixed Models Analysis
Comparison: Growth curve models examined the following: group (BN versus HC) differences in conflict-related BOLD signal at baseline; group differences in the rate of change in conflict-related BOLD signal over time; and the persistence of group differences in conflict-related BOLD signal over time.p-value: <0.0595% CI: [-0.04, 0.15]Mixed Models Analysis
Secondary
Conners Continuous Performance Test-II (CPT-II)
The 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)
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adolescents With Bulimia Nervosa or Subclinical BN | Conners Continuous Performance Test-II (CPT-II) | Commissions | 53.31 T-scores | Standard Deviation 8.25 |
| Adolescents With Bulimia Nervosa or Subclinical BN | Conners Continuous Performance Test-II (CPT-II) | Hit Reaction Time Standard Error | 45.81 T-scores | Standard Deviation 9.38 |
| Adolescents With Bulimia Nervosa or Subclinical BN | Conners Continuous Performance Test-II (CPT-II) | Hit Reaction Time | 39.71 T-scores | Standard Deviation 7.33 |
| Adolescents With Bulimia Nervosa or Subclinical BN | Conners Continuous Performance Test-II (CPT-II) | Detectability | 54.18 T-scores | Standard Deviation 6.47 |
| Adolescents With Bulimia Nervosa or Subclinical BN | Conners Continuous Performance Test-II (CPT-II) | Omissions | 49.52 T-scores | Standard Deviation 12.48 |
| Healthy Control Adolescents | Conners Continuous Performance Test-II (CPT-II) | Detectability | 50.98 T-scores | Standard Deviation 10.5 |
| Healthy Control Adolescents | Conners Continuous Performance Test-II (CPT-II) | Omissions | 53.24 T-scores | Standard Deviation 16.5 |
| Healthy Control Adolescents | Conners Continuous Performance Test-II (CPT-II) | Commissions | 50.20 T-scores | Standard Deviation 12.3 |
| Healthy Control Adolescents | Conners Continuous Performance Test-II (CPT-II) | Hit Reaction Time | 45.57 T-scores | Standard Deviation 13.41 |
| Healthy Control Adolescents | Conners Continuous Performance Test-II (CPT-II) | Hit Reaction Time Standard Error | 49.23 T-scores | Standard Deviation 11.06 |
Secondary
Stroop Word-Color Interference
The 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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescents With Bulimia Nervosa or Subclinical BN | Stroop Word-Color Interference | 22.1 score on a scale | Standard Deviation 6 |
| Healthy Control Adolescents | Stroop Word-Color Interference | 21.5 score on a scale | Standard Deviation 5 |
Secondary
Weather Prediction Task
The 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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescents With Bulimia Nervosa or Subclinical BN | Weather Prediction Task | 54.9 percentage of correct response | Standard Deviation 11.5 |
| Healthy Control Adolescents | Weather Prediction Task | 51.4 percentage of correct response | Standard Deviation 10.4 |