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

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

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 ]
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:

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.


Enrollment:	71
Study Start Date:	October 2004
Estimated Study Completion Date:	September 2017
Estimated Primary Completion Date:	September 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

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)
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

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):

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
Study First Received:	June 28, 2006
Last Updated:	June 12, 2017
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

ClinicalTrials.gov processed this record on August 18, 2017