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

NCT01935401 | Completed

• 1 other identifier: 1F31MH097406
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Bulimia Nervosa

Keywords

Bulimia Nervosa; Bulimia; Response Inhibition; fNIR; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• Functional near-infrared spectroscopy

  Day 1

Secondary Outcomes (9)

• Body mass index

  Day 1 and 1 year

• Eating disorder examination (EDE)

  Day 1 and 1 Year

• Wechsler Abbreviated Scale of Intelligence (WASI™)

  Day 1

• Mini-International Neuropsychiatric Interview (MINI)

  Day 1

• Button pressing go/no-go task

  Day 1

Study Arms (2)

Women with Bulimia Nervosa

fNIR \- Functional near-infrared spectroscopy measured-brain activity

Healthy Controls

fNIR \- Functional near-infrared spectroscopy measured-brain activity

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women (ages 18-45 years) with bulimia nervosa and age, BMI, and IQ-matched controls.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Lowe: lead

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Bulimia Nervosa; Bulimia

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael R Lowe, Ph.D.

  Drexel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: September 5, 2013
• Study Start: June 1, 2011
• Primary Completion: September 1, 2014
• Last Updated: October 7, 2014

Record last verified: 2014-10

Locations

US (1)