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

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00345943

Purpose

The aim of this project is to use both functional MRI (fMRI) and behavioral measures to investigate how disturbances in frontostriatal neural systems contribute to the impulsive and habitual binge-eating behaviors in patients with 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: fMRI Behavioral: Neuropsychological Testing

MedlinePlus related topics: Eating Disorders MRI Scans

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	An fMRI Study of Self-Regulation in Adolescents With Bulimia Nervosa

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Functional magnetic resonance imaging scan [ Time Frame: Measured at a single visit ] [ 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 a single visit ] [ Designated as safety issue: No ]
Rotary Pursuit [ Time Frame: Measured at a single visit ] [ Designated as safety issue: No ]
Mirror Tracing [ Time Frame: Measured at a single visit ] [ Designated as safety issue: No ]
Stroop Word-Color Interference [ Time Frame: Measured at a single visit ] [ Designated as safety issue: No ]
Weather Prediction Task [ Time Frame: Measured at a single visit ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	80
Study Start Date:	October 2004
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa	Other: fMRI Functional Magnetic Resonance Imaging scans Behavioral: Neuropsychological Testing Neuropsychological tests
2 Healthy control adolescents	Other: fMRI Functional Magnetic Resonance Imaging scans Behavioral: Neuropsychological Testing Neuropsychological tests

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. Thus we aim to use fMRI and neuropsychological measures to investigate the functioning of frontostriatal systems and self-regulatory control processes in adolescents with 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.

Eligibility

Ages Eligible for Study:	12 Years to 21 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Adolescents (ages 12-21 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

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

Contacts

Contact: Laura J. Berner, BA	212-543-5316	lb2518@columbia.edu
Contact: Rebecca Shingleton, MA	212-543-5151	rshingl@pi.cpmc.columbia.eduedu

Locations

United States, New York
New York State Psychiatric Institute at Columbia University Medical Center	Recruiting
New York, New York, United States, 10032

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Rachel Marsh, PhD

Columbia University

More Information

Responsible Party:	The New York State Psychiatric Institute ( Rachel Marsh, PhD )
Study ID Numbers:	K01 MH77652
Study First Received:	June 28, 2006
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00345943
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Eating Disorders
Bulimia Nervosa
Bulimia
fMRI
Magnetic Resonance Imaging

Study placed in the following topic categories:

Signs and Symptoms
Bulimia Nervosa
Signs and Symptoms, Digestive
Mental Disorders

Bulimia
Eating Disorders
Hyperphagia

ClinicalTrials.gov processed this record on January 30, 2009