Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH090062 | U.S. NIH Grant/Contract | View source | |
| DDTR M2-MBB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescents with Bulimia Nervosa or subclinical BN | Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa |
| |
| Healthy control adolescents | Healthy control adolescents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Other | Magnetic Resonance Imaging scans |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Adolescents (ages 12-17 years) with bulimia nervosa and age, gender, and weight-matched controls
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rachel Marsh, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute at Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30846367 | Derived | Berner LA, Wang Z, Stefan M, Lee S, Huo Z, Cyr M, Marsh R. Subcortical Shape Abnormalities in Bulimia Nervosa. Biol Psychiatry Cogn Neurosci Neuroimaging. 2019 Dec;4(12):1070-1079. doi: 10.1016/j.bpsc.2018.12.011. Epub 2019 Jan 4. | |
| 27806864 | Derived | Cyr M, Wang Z, Tau GZ, Zhao G, Friedl E, Stefan M, Terranova K, Marsh R. Reward-Based Spatial Learning in Teens With Bulimia Nervosa. J Am Acad Child Adolesc Psychiatry. 2016 Nov;55(11):962-971.e3. doi: 10.1016/j.jaac.2016.07.778. Epub 2016 Sep 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adolescents With Bulimia Nervosa or Subclinical BN | Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa MRI: Magnetic Resonance Imaging scans Neuropsychological Testing: Neuropsychological tests |
| FG001 | Healthy Control Adolescents | Healthy control adolescents MRI: Magnetic Resonance Imaging scans Neuropsychological Testing: Neuropsychological tests |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adolescents With Bulimia Nervosa or Subclinical BN | Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa MRI: Magnetic Resonance Imaging scans Neuropsychological Testing: Neuropsychological tests |
| BG001 | Healthy Control Adolescents |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | mm | Baseline |
|
5 years (Year 1-5)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adolescents With Bulimia Nervosa or Subclinical BN | Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa MRI: Magnetic Resonance Imaging scans Neuropsychological Testing: Neuropsychological tests |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rachel Marsh | New York State Psychiatric Institute | 6467745774 | rachel.marsh@nyspi.columbia.edu |
Not provided
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D052018 | Bulimia Nervosa |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D056324 | Diffusion Tensor Imaging |
| D009483 | Neuropsychological Tests |
| ID | Term |
|---|---|
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
| Neuropsychological Testing | Behavioral | Neuropsychological tests |
|
|
| Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 19448188 | Derived | Marsh R, Maia TV, Peterson BS. Functional disturbances within frontostriatal circuits across multiple childhood psychopathologies. Am J Psychiatry. 2009 Jun;166(6):664-74. doi: 10.1176/appi.ajp.2009.08091354. Epub 2009 May 15. |
Healthy control adolescents MRI: Magnetic Resonance Imaging scans Neuropsychological Testing: Neuropsychological tests |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Wechsler Abbreviated Intelligence Scale (WASI) | This estimates Full Scale IQ with excellent reliability and validity for ages 6-90. The measure is comprised of 4-subtests: block design task, vocabulary task, matrix reasoning test and similarities test. A composite score is calculated by summing the scores on the 4 subtests. Standard score ranges: Superior: >130; Very High: 120-129; Bright normal: 110-119; Average: 90-109; Low Average: 80-89; Borderline Mental Functioning: 70-79 | Mean | Standard Deviation | units on a scale |
|
| Illness duration | This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group | Mean | Standard Deviation | months |
|
| Eating Disorder Examination - objective binge eating episodes (past 28 days) | This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group | Mean | Standard Deviation | Number of episodes |
|
| Eating Disorder Examination - subjective binge eating episodes (past 28 days) | This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group | Mean | Standard Deviation | Number of episodes |
|
| Eating Disorder Examination - self-induced vomiting episodes (past 28 days) | This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group | Mean | Standard Deviation | Number of episodes |
|
| Eating Disorder Examination - loss of control episodes (past 28 days) | This clinical measure was only administered to the Adolescents with Bulimia Nervosa or subclinical BN group | Mean | Standard Deviation | Number of episodes |
|
| Comorbid Major Depressive Disorder | Any lifetime Axis I disorder (including Major Depressive Disorder) was exclusionary for the Healthy control group | Number | participants |
|
| Comorbid Anxiety Disorders | Any lifetime Axis I disorders (including Anxiety disorders) was exclusionary for the Healthy Control group | Number | participants |
|
| Psychotropic Medication Use | Psychotropic medication use was exclusionary for the Healthy Control group | Number | participants |
|
| Prior Anorexia Nervosa (%) | Any lifetime Axis I disorders (including Anorexia Nervosa) was exclusionary for the Healthy Control group | Count of Participants | Participants |
|
| Inpatient Treatment | Ongoing psychiatric treatment was exclusionary for the Healthy control group | Number | participants |
|
| Outpatient Treatment | Ongoing psychiatric treatment was exclusionary for the Healthy control group | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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) | Posted | Mean | Standard Deviation | T-scores | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of correct response | Baseline |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Healthy Control Adolescents | Healthy control adolescents MRI: Magnetic Resonance Imaging scans Neuropsychological Testing: Neuropsychological tests | 0 | 33 | 0 | 33 | 0 | 33 |
Not provided
Not provided
| D006963 | Hyperphagia |
| D038524 |
| Diffusion Magnetic Resonance Imaging |
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hit Reaction Time |
|
| Hit Reaction Time Standard Error |
|
| Detectability |
|