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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00345943
First received: June 28, 2006
Last updated: May 17, 2016
Last verified: May 2016
History of Changes
  Purpose
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 Intervention
Eating Disorders
 Other: MRI
Behavioral: Neuropsychological Testing

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Magnetic resonance imaging scans [ Time Frame: Measured at baseline and follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wechsler Abbreviated Scale of Intelligence (WASI) [ Time Frame: Measured at a single visit ] [ Designated as safety issue: No ]
  • Continuous Performance Task [ Time Frame: Measured at baseline and follow-up ] [ Designated as safety issue: No ]
  • Stroop Word-Color Interference [ Time Frame: Measured at baseline and follow-up ] [ Designated as safety issue: No ]
  • Weather Prediction Task [ Time Frame: Measured at baseline and follow-up ] [ Designated as safety issue: No ]
  • Silverman [ Time Frame: Measured at baseline and follow-up ] [ Designated as safety issue: No ]
Estimated Enrollment: 80
Study Start Date: October 2004
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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
2
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

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.

  Eligibility
Ages Eligible for Study:   12 Years to 17 Years   (Child)
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345943

Locations
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
Principal Investigator: Rachel Marsh, PhD Columbia University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00345943     History of Changes
Other Study ID Numbers: #5606R/6679R  R01MH090062  DDTR M2-MBB 
Study First Received: June 28, 2006
Last Updated: May 17, 2016
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Eating Disorders
Bulimia Nervosa
Bulimia
fMRI
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Feeding and Eating Disorders
Bulimia
Bulimia Nervosa
Mental Disorders
 Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2016