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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345943
First Posted: June 29, 2006
Last Update Posted: June 14, 2017
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
June 28, 2006
June 29, 2006
June 14, 2017
October 2004
September 2017   (Final data collection date for primary outcome measure)
Magnetic resonance imaging scans [ Time Frame: Measured at baseline and follow-up ]
This study will use magnetic resonance imaging (MRI) to assess the structure, function, and connectivity of neural circuits involved in Bulimia Nervosa (BN).
Not Provided
Complete list of historical versions of study NCT00345943 on ClinicalTrials.gov Archive Site
  • Wechsler Abbreviated Scale of Intelligence (WASI) [ Time Frame: Measured at a single visit ]
    This estimates Full Scale IQ with excellent reliability and validity for ages 6-90.
  • Continuous Performance Task [ Time Frame: Measured at baseline and follow-up ]
    The Continuous Performance Task (CPT) is a standardized measure of sustained attention and impulsivity.
  • Stroop Word-Color Interference [ Time Frame: Measured at baseline and follow-up ]
    This is a classic task of cognitive interference that is comprised of 3 subtasks.
  • Weather Prediction Task [ Time Frame: Measured at baseline and follow-up ]
    The Weather Prediction Task is a measure of probabilistic learning.
  • Silverman [ Time Frame: Measured at baseline and follow-up ]
    This measure consists of one stimulus card and two response cards, each depicting a spatial array of common objects.
Not Provided
Not Provided
Not Provided
 
An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa
An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa
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.

Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Adolescents (ages 12-17 years) with bulimia nervosa and age, gender, and weight-matched controls
Eating Disorders
  • 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
  • Adolescents with Bulimia Nervosa or subclinical BN
    Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
    Interventions:
    • Other: MRI
    • Behavioral: Neuropsychological Testing
  • Healthy control adolescents
    Healthy control adolescents
    Interventions:
    • Other: MRI
    • Behavioral: Neuropsychological Testing

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
71
September 2017
September 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
12 Years to 17 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00345943
#5606R/6679R
R01MH090062 ( U.S. NIH Grant/Contract )
DDTR M2-MBB
Yes
Not Provided
Plan to Share IPD: Yes
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: Rachel Marsh, PhD Columbia University
New York State Psychiatric Institute
June 2017
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