Self-regulatory Control and Eating: A Neuroimaging Study of Bulimia Nervosa

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. Identifier: NCT01935401
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : October 7, 2014
Information provided by (Responsible Party):
Michael Lowe, Drexel University

Brief Summary:
The purpose of this study will be to replicate previous findings of deficits in prefrontal activation during response inhibition tasks in bulimia nervosa and extend these findings by demonstrating similar deficiencies in activity during a functional behavioral task that requires the inhibition of eating. Findings from this study will potentially help to elucidate the underlying neural mechanisms of bulimia nervosa, and thus inform treatment and prevention efforts.

Condition or disease
Bulimia Nervosa

Detailed Description:

Bulimia nervosa (BN), is a serious psychiatric disorder that has high rates of comorbidity and often results in role impairment for the suffer. Thus far, although psychosocial and behavioral risk factors and correlates of BN have been extensively researched, relatively few studies have focused on brain-based determinants of BN. Identification of neural mechanisms associated with self-regulatory control that may be integral in the development, maintenance, and prevention of this debilitating condition would better inform treatment development and eating disorder prevention efforts.

Participation in this study consists of a 3-3.5 hours study visit as well a a one year follow up visit. The first portion of initial study visit is part of the screening process, in which individuals will complete several questionnaires and be interviewed by the study researcher in order to confirm eligibility. If a participant is eligible after the screening portion, they move onto the rest of the initial visit. During the initial visit, participants will complete a button pressing go/no-go task as well as a sipping go/no-go task, all while wearing a functional near-infrared spectroscopy (fNIR) device.

At a one year follow up appointment, individuals will again complete a variety of self-report questionnaires and be interviewed by the study researcher, thus completing the same measures used as screening tools in the initial visit.

Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Self-regulatory Control and Eating: A Neuroimaging Study of Bulimia Nervosa
Study Start Date : June 2011
Actual Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

Women with Bulimia Nervosa


- Functional near-infrared spectroscopy measured-brain activity

Healthy Controls


- Functional near-infrared spectroscopy measured-brain activity

Primary Outcome Measures :
  1. Functional near-infrared spectroscopy [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Body mass index [ Time Frame: Day 1 and 1 year ]
    Body mass index, calculated from height and weight measurements

  2. Eating disorder examination (EDE) [ Time Frame: Day 1 and 1 Year ]
    Used to assess eating disorder symptom frequency and severity, including binge eating episode frequency.

  3. Wechsler Abbreviated Scale of Intelligence (WASI™) [ Time Frame: Day 1 ]
  4. Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: Day 1 ]
  5. Button pressing go/no-go task [ Time Frame: Day 1 ]
  6. Go/no-go sipping task [ Time Frame: Day 1 ]
  7. Psychosocial self-report measures [ Time Frame: Day 1 and 1 Year ]
    Measures to be administered include: Power of Food Scale (PFS), Beck Anxiety Inventory (BAI), Center for Epidemiological Studies Depression Scale (CES-D), Barratt Impulsivity Scale, Version 11 (BIS), Eating Loss of Control Scale (ELOCS), Difficulties in Emotion Regulation Scale (DERS), and Behavioral Inhibition and Behavioral Activation (BIS/BAS) Scales

  8. Positive and Negative Affect Schedule (PANAS) [ Time Frame: Day 1 ]
    This measure will assess mood ratings before the participant completes the standard go/no-go task and the sipping go/no-go task

  9. Generalized Labeled Magnitude Scale (gLMS) [ Time Frame: Day 1 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women (ages 18-45 years) with bulimia nervosa and age, BMI, and IQ-matched controls.

Inclusion Criteria:

  • Female
  • Right-handed
  • Age 18-45
  • Between 85 and 120% of ideal body weight based on height
  • Currently meeting proposed DSM-5 criteria for Bulimia Nervosa (at least one objective bulimic episode and compensatory purging episode per week for the past three months)
  • Purging via self-induced vomiting
  • Duration of illness of at least 6 months

Exclusion Criteria:

  • Current significant medical illness
  • Any disorder or condition resulting in difficulty swallowing (e.g., dysphagia)
  • History of neurological disorders or diseases (e.g., stroke, seizures, heart disease, head trauma with loss of consciousness)
  • Drug or alcohol abuse in the past 6 months or any history of alcohol or drug dependence
  • Use of marijuana or any other illegal drug (e.g., cocaine, heroin, ecstasy) in the week before the study visit
  • IQ less than 75
  • Pregnancy, lactation, or planning to become pregnant in the next year
  • Allergy to sucrose, dairy, wheat, gluten, apples (i.e., any of the ingredients in the strawberry yogurt shake or in the standardized meal prior to study participation)
  • Participants rating the strawberry yogurt shake as a 5 or lower on a 9-point category scale of liking will be excluded from further study
  • Meeting the criteria for a diagnosis of Attention Deficit Hyperactivity Disorder
  • Any other current major Axis I disorder, other than major depressive disorder (MDD) or generalized anxiety disorder (GAD)
  • Inability to consent
  • Prisoner

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01935401

United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Michael Lowe
Principal Investigator: Michael R Lowe, Ph.D. Drexel University

Responsible Party: Michael Lowe, PI, Drexel University Identifier: NCT01935401     History of Changes
Other Study ID Numbers: 1F31MH097406 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014

Keywords provided by Michael Lowe, Drexel University:
Bulimia Nervosa
Response Inhibition

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