An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa
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ClinicalTrials.gov Identifier: NCT00345943 |
Recruitment Status :
Completed
First Posted : June 29, 2006
Results First Posted : December 2, 2021
Last Update Posted : December 2, 2021
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Condition or disease | Intervention/treatment |
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Eating Disorders | Other: MRI Behavioral: Neuropsychological Testing |
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.
Study Type : | Observational |
Actual Enrollment : | 71 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa |
Study Start Date : | October 2004 |
Actual Primary Completion Date : | September 2016 |
Actual Study Completion Date : | August 2021 |
Group/Cohort | Intervention/treatment |
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Adolescents with Bulimia Nervosa or subclinical BN
Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
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Other: MRI
Magnetic Resonance Imaging scans
Other Names:
Behavioral: Neuropsychological Testing Neuropsychological tests
Other Names:
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Healthy control adolescents
Healthy control adolescents
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Other: MRI
Magnetic Resonance Imaging scans
Other Names:
Behavioral: Neuropsychological Testing Neuropsychological tests
Other Names:
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- Magnetic Resonance Imaging Scans [ Time Frame: Baseline ]This study will use magnetic resonance imaging (MRI) to assess the structure (cortical thickness) of neural circuit regions involved in Bulimia Nervosa (BN).
- Conners Continuous Performance Test-II (CPT-II) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 12 Years to 17 Years (Child) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345943
United States, New York | |
New York State Psychiatric Institute at Columbia University Medical Center | |
New York, New York, United States, 10032 |
Principal Investigator: | Rachel Marsh, PhD | Columbia University |
Responsible Party: | Rachel Marsh, Research Scientist, New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT00345943 |
Other Study ID Numbers: |
#5606R/6679R R01MH090062 ( U.S. NIH Grant/Contract ) DDTR M2-MBB |
First Posted: | June 29, 2006 Key Record Dates |
Results First Posted: | December 2, 2021 |
Last Update Posted: | December 2, 2021 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Eating Disorders Bulimia Nervosa Bulimia fMRI Magnetic Resonance Imaging |
Bulimia Feeding and Eating Disorders Bulimia Nervosa |
Mental Disorders Hyperphagia Signs and Symptoms, Digestive |