NCT03393039Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 410 (estimated)
- First submitted
- 28 Dec 2017
- Start date
- 1 Feb 2018
- Primary completion date
- Jan 2027
- Lead sponsor
- University of California, San Diego
- Diseases
- Obesity
- NCT number
- NCT03393039
What you commit to
- Study type: Interventional
- Planned participants: 410
- From 1 Feb 2018 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current Medications other than BCP or IUD
- Metal implants or braces
- Obese
- Current or previous eating disorder diagnosis
- Current Medications other than BCP or IUD
- Use of a psychostimulant within the prior 6 months
- Metal implants or braces
- Bulimia Nervosa
- Use of a psychostimulant within the prior 6 months
- Metal implants or braces
Other illness
- First degree relative with current or past eating disorder
- 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
- First degree relative with current or past eating disorder
- 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
- Lifetime history of bipolar disorder or psychosis
- Recent history of substance abuse or dependence (except for alcohol and cannabis use)
- Major Medical illness
- Lifetime history of bipolar disorder or psychosis
- Recent history of substance abuse or dependence (except for alcohol and cannabis use)
- Major Medical illness
Other
- Healthy Controls
- Current pregnancy or breast feeding within last 3 months
- Current pregnancy or breast feeding within last 3 months
- Pregnancy or breast feeding within last 3 months
- Pregnancy or breast feeding within last 3 months
Who the study is looking for
- 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.
- At least once a week for 3 months. D. Self-evaluation is unduly influenced by body shape and weight.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California At San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.