Clinical trial NCT01935401: Self-regulatory Control and Eating: A Neuroimaging Study of Bulimia Nervosa
Official title: Self-regulatory Control and Eating: A Neuroimaging Study of Bulimia Nervosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bulimia Nervosa
Keywords: Bulimia Nervosa
Bulimia
Response Inhibition
fNIR
Neuroimaging
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women (ages 18-45 years) with bulimia nervosa and age, BMI, and IQ-matched controls.

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.

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 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

Primary outcomes:
measure: Functional near-infrared spectroscopy
timeFrame: Day 1
Secondary outcomes:
measure: Body mass index
timeFrame: Day 1 and 1 year
measure: Eating disorder examination (EDE)
timeFrame: Day 1 and 1 Year
measure: Wechsler Abbreviated Scale of Intelligence (WASI™)
timeFrame: Day 1
measure: Mini-International Neuropsychiatric Interview (MINI)
timeFrame: Day 1
measure: Button pressing go/no-go task
timeFrame: Day 1
measure: Go/no-go sipping task
timeFrame: Day 1
measure: Psychosocial self-report measures
timeFrame: Day 1 and 1 Year
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Day 1
measure: Generalized Labeled Magnitude Scale (gLMS)
timeFrame: Day 1
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Michael R Lowe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: