Trial record 3 of 32 for:    Open Studies | "Bulimia"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Drexel University
Sponsor:
Information provided by (Responsible Party):
Michael Lowe, Drexel University
ClinicalTrials.gov Identifier:
NCT01935401
First received: August 5, 2013
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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
Bulimia Nervosa

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Self-regulatory Control and Eating: A Neuroimaging Study of Bulimia Nervosa

Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Functional near-infrared spectroscopy [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body mass index [ Time Frame: Day 1 and 1 year ] [ Designated as safety issue: No ]
    Body mass index, calculated from height and weight measurements

  • Eating disorder examination (EDE) [ Time Frame: Day 1 and 1 Year ] [ Designated as safety issue: No ]
    Used to assess eating disorder symptom frequency and severity, including binge eating episode frequency.

  • Wechsler Abbreviated Scale of Intelligence (WASI™) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Button pressing go/no-go task [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Go/no-go sipping task [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Psychosocial self-report measures [ Time Frame: Day 1 and 1 Year ] [ Designated as safety issue: No ]
    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

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

  • Generalized Labeled Magnitude Scale (gLMS) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: June 2011
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women with Bulimia Nervosa

fNIR

- Functional near-infrared spectroscopy measured-brain activity

Healthy Controls

fNIR

- Functional near-infrared spectroscopy measured-brain activity


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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.

Criteria

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
  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: NCT01935401

Contacts
Contact: Laura A Berner, M.S. 215-553-7133 fNIRSipStudy@drexel.edu

Locations
United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Laura A Berner, M.A.    215-553-7133    fNIRSipStudy@drexel.edu   
Sponsors and Collaborators
Michael Lowe
Investigators
Principal Investigator: Michael R Lowe, Ph.D. Drexel University
  More Information

No publications provided

Responsible Party: Michael Lowe, PI, Drexel University
ClinicalTrials.gov Identifier: NCT01935401     History of Changes
Other Study ID Numbers: 1F31MH097406
Study First Received: August 5, 2013
Last Updated: February 25, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Drexel University:
Bulimia Nervosa
Bulimia
Response Inhibition
fNIR
Neuroimaging

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

ClinicalTrials.gov processed this record on July 22, 2014