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临床试验/NCT01935401
NCT01935401已完成不适用

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

Michael Lowe1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Michael Lowe
入组人数
47
试验地点
1
主要终点
Functional near-infrared spectroscopy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Functional near-infrared spectroscopy

时间窗: Day 1

次要结局

  • Generalized Labeled Magnitude Scale (gLMS)(Day 1)
  • Button pressing go/no-go task(Day 1)
  • Eating disorder examination (EDE)(Day 1 and 1 Year)
  • Go/no-go sipping task(Day 1)
  • Body mass index(Day 1 and 1 year)
  • Wechsler Abbreviated Scale of Intelligence (WASI™)(Day 1)
  • Positive and Negative Affect Schedule (PANAS)(Day 1)
  • Mini-International Neuropsychiatric Interview (MINI)(Day 1)
  • Psychosocial self-report measures(Day 1 and 1 Year)

研究者

发起方
Michael Lowe
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael Lowe

PI

Drexel University

研究点 (1)

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