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Effects of Negative Affect in Individuals With Binge Eating Episodes
Binge-eating is characterized by recurrent episodes of eating large amounts of - typically high calorie - foods, eating much more rapidly than normal and until feeling uncomfortably full, as well as feeling disgusted with oneself, depressed, or guilty after those episodes. Two eating disorders are characterized by binge-eating as central diagnostic criteria, binge-eating disorder (BED) and bulimia nervosa (BN). Binge-eating episodes in BN, but not BED, are typically followed by compensatory mechanisms such as self-induced vomiting, and BED is typically associated with obesity, while BN is not. Behavior studies such as ecological momentary assessment (EMA) research of affect in an individual's naturalistic environment have shown that negative affect and negative urgency (the tendency to act rashly when distressed) often precede binge-eating. The Investigators want to answer the following questions: Can negative affect in BN and BED be linked to 1) altered dopamine related brain reinforcement learning, 2) to food value computation and cognitive control circuit function, and 3) can dopamine related brain activation predict eating and negative affect, indicating a brain based neurobiological vulnerability. Answering those questions will help to define binge-eating based on regulation of brain reward, cognition, and emotion circuit function and point toward potential psychopharmacological interventions to normalize brain function and behavior.
Conditions:
🦠 Bulimia Nervosa 🦠 Binge-Eating Disorder 🦠 Obesity 🦠 Eating Disorder
🗓️ Study Start (Actual) 1 February 2018
🗓️ Primary Completion (Estimated) 30 April 2024
✅ Study Completion (Estimated) 30 April 2024
👥 Enrollment (Estimated) 410
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 San Diego, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • Healthy Controls
    • * Age 18-55 years old
    • * Healthy body weight between 90 and 110 % average body weight since puberty.
    • * Regular monthly menstrual cycle (if applicable)
    • * Edinburgh Handedness Inventory Revised (EHI-R) LQ\* score \> +200
    • Obese
    • * Age 18-55 years old
    • * Current body mass index (BMI) \> 30 kg/m2.
    • * Stable food intake regimen in previous 4 weeks.
    • * Edinburgh Handedness Inventory Revised (EHI-R) LQ\* score \> +200
    • * Obese for at least one year
    • Binge Eating Disorder
    • * Age 18-55 years old
    • * Edinburgh Handedness Inventory Revised (EHI-R) LQ\* score \> +200
    • * DSM 5 diagnosis of Binge Eating Disorder A. Recurrent episodes of binge eating B. Binge eating episodes are associated with three (or more) of the following
    • 1. Eating much more rapidly than normal.
    • 2. Eating until feeling uncomfortably full.
    • 3. Eating large amounts of food when not feeling physically hungry.
    • 4. Eating alone because of embarrassment.
    • 5. Feeling disgusted with oneself, depressed, or very guilty after overeating. C. Marked distress regarding binge eating is present. D. At least once a week for 3 months. E. The binge eating is not associated with the recurrent use of inappropriate compensatory behavior.
    • Bulimia Nervosa
    • * Age 18-55 years old
    • * Edinburgh Handedness Inventory Revised (EHI-R) LQ\* score \> +200
    • * DSM 5 diagnosis of Bulimia Nervosa A. Recurrent episodes of binge eating Eating, in a discrete period of time, an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances.
    • A sense of lack of control over eating during the episode. B. Recurrent inappropriate compensatory behavior in order to prevent weight gain, such as self-induced vomiting; misuse of laxatives, diuretics, or other medications; fasting; or excessive exercise.
    • C. At least once a week for 3 months. D. Self-evaluation is unduly influenced by body shape and weight.

    Exclusion Criteria:

    • Healthy Controls
    • * Current pregnancy or breast feeding within last 3 months
    • * First degree relative with current or past eating disorder
    • * Current Medications other than BCP or IUD
    • * Past or present Axis I psychiatric disorder including substance or alcohol use disorder as determined through SCID-5 clinical interview
    • * First degree relative with an eating disorder
    • * Major Medical illness
    • * Recent history of suspected substance abuse or a lifetime history of psychostimulant abuse and/or dependence
    • * Metal implants or braces
    • Obese
    • * Current pregnancy or breast feeding within last 3 months
    • * First degree relative with current or past eating disorder
    • * Current or previous eating disorder diagnosis
    • * Current Medications other than BCP or IUD
    • * Past or present Axis I psychiatric disorder including substance or alcohol use disorder as determined through SCID-5 clinical interview
    • * Major Medical illness
    • * Recent history of suspected substance abuse or a lifetime history of psychostimulant abuse and/or dependence
    • * Metal implants or braces
    • Binge Eating Disorder
    • * Pregnancy or breast feeding within last 3 months
    • * Lifetime history of bipolar disorder or psychosis
    • * Use of a psychostimulant within the prior 6 months
    • * Recent history of substance abuse or dependence (except for alcohol and cannabis use)
    • * Major Medical illness
    • * Metal implants or braces
    • Bulimia Nervosa
    • * Pregnancy or breast feeding within last 3 months
    • * Lifetime history of bipolar disorder or psychosis
    • * Use of a psychostimulant within the prior 6 months
    • * Recent history of substance abuse or dependence (except for alcohol and cannabis use)
    • * Major Medical illness
    • * Metal implants or braces
Ages Eligible for Study: 18 Years to 55 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 December 2017
  • First Submitted that Met QC Criteria 4 January 2018
  • First Posted 8 January 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 November 2023
  • Last Update Posted 21 November 2023
  • Last Verified November 2023
I'm interested ...!!