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An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00345943
Recruitment Status : Completed
First Posted : June 29, 2006
Results First Posted : December 2, 2021
Last Update Posted : December 2, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rachel Marsh, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment
Eating Disorders Other: MRI Behavioral: Neuropsychological Testing

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Group/Cohort Intervention/treatment
Adolescents with Bulimia Nervosa or subclinical BN
Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
Other: MRI
Magnetic Resonance Imaging scans
Other Names:
  • GE 3T scanner
  • Anatomical Images, DTI, and MRS

Behavioral: Neuropsychological Testing
Neuropsychological tests
Other Names:
  • Wechsler Abbreviated Scale of Intelligence (WASI)
  • Continuous Performance Task
  • Stroop Word-Color Interference
  • Weather Prediction Task

Healthy control adolescents
Healthy control adolescents
Other: MRI
Magnetic Resonance Imaging scans
Other Names:
  • GE 3T scanner
  • Anatomical Images, DTI, and MRS

Behavioral: Neuropsychological Testing
Neuropsychological tests
Other Names:
  • Wechsler Abbreviated Scale of Intelligence (WASI)
  • Continuous Performance Task
  • Stroop Word-Color Interference
  • Weather Prediction Task




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)


  2. 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.


  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Study Population
Adolescents (ages 12-17 years) with bulimia nervosa and age, gender, and weight-matched controls
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, New York
New York State Psychiatric Institute at Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Rachel Marsh, PhD Columbia University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Keywords provided by Rachel Marsh, New York State Psychiatric Institute:
Eating Disorders
Bulimia Nervosa
Bulimia
fMRI
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Bulimia
Feeding and Eating Disorders
Bulimia Nervosa
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive