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Completed

NCT Number: NCT01935401

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Functional near-infrared spectroscopy

    Time frame: Day 1

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Michael Lowe

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
First posted
Sep 5, 2013
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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