- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03393039
Effects of Negative Affect in Individuals With Binge Eating Episodes
Neural Effects of Negative Affect on Food Choices and Reward 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92121
- University of California at San Diego
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
- Eating much more rapidly than normal.
- Eating until feeling uncomfortably full.
- Eating large amounts of food when not feeling physically hungry.
- Eating alone because of embarrassment.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Behavioral
Negative Affect Task
|
fMRI stress task
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Taste Reward Brain Response to Negative Affect fMRI Task
Time Frame: 5 years
|
to study brain activation in a taste reward task in response to negative affect
|
5 years
|
|
Food Choice Brain Response to Negative Affect fMRI Task
Time Frame: 5 years
|
to study brain activation in a food choice task in response to negative affect
|
5 years
|
|
Brain Activation and Food Intake/negative Affect Relationships
Time Frame: 5 years
|
To test whether brain activation predicts food intake or negative affect
|
5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Guido KW Frank, MD, University of California, San Diego
Publications and helpful links
General Publications
- Engel SG, Kahler KA, Lystad CM, Crosby RD, Simonich HK, Wonderlich SA, Peterson CB, Mitchell JE. Eating behavior in obese BED, obese non-BED, and non-obese control participants: a naturalistic study. Behav Res Ther. 2009 Oct;47(10):897-900. doi: 10.1016/j.brat.2009.06.018. Epub 2009 Jul 7.
- Berg KC, Crosby RD, Cao L, Crow SJ, Engel SG, Wonderlich SA, Peterson CB. Negative affect prior to and following overeating-only, loss of control eating-only, and binge eating episodes in obese adults. Int J Eat Disord. 2015 Sep;48(6):641-53. doi: 10.1002/eat.22401. Epub 2015 Mar 23.
- Pearson CM, Wonderlich SA, Smith GT. A risk and maintenance model for bulimia nervosa: From impulsive action to compulsive behavior. Psychol Rev. 2015 Jul;122(3):516-35. doi: 10.1037/a0039268. Epub 2015 May 11.
- Racine SE, Burt SA, Keel PK, Sisk CL, Neale MC, Boker S, Klump KL. Examining associations between negative urgency and key components of objective binge episodes. Int J Eat Disord. 2015 Jul;48(5):527-31. doi: 10.1002/eat.22412. Epub 2015 Apr 10.
- Engel SG, Crosby RD, Thomas G, Bond D, Lavender JM, Mason T, Steffen KJ, Green DD, Wonderlich SA. Ecological Momentary Assessment in Eating Disorder and Obesity Research: a Review of the Recent Literature. Curr Psychiatry Rep. 2016 Apr;18(4):37. doi: 10.1007/s11920-016-0672-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-2658
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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