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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Estimated Primary Completion Date :	May 2018
Estimated Study Completion Date :	May 2018

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. Weather Prediction Task [ Time Frame: Measured at baseline and follow-up ]
   The Weather Prediction Task is a measure of probabilistic learning.
5. 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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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.

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. Review.

Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00345943 History of Changes
Other Study ID Numbers:	#5606R/6679R; R01MH090062 ( U.S. NIH Grant/Contract ); DDTR M2-MBB
First Posted:	June 29, 2006
Last Update Posted:	February 14, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes

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