ClinicalTrials.gg
Active, not recruitingNCT03393039Updated Aug 3, 2026

Effects of Negative Affect in Individuals With Binge Eating Episodes

An interventional study of Negative Affect Task in Bulimia Nervosa, Binge-Eating Disorder and Obesity, sponsored by University of California, San Diego. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
410
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 87 studies in Bulimia Nervosa with a site in United States — 15 open to participants now, 21 under way, none of them phase 3. Bulimia Nervosa · United States.

Planned enrollment
3rd of 68
410 · median 42
Started
2018
with 2 others
No phase
56 of 87
10 open now
Primary completion
2027-01
later than 5 of 20 live
Registered
41st of 87
by date
Lead sponsor
8 of 87
University of California, San Diego

Among the 87 studies in Bulimia Nervosa with a site in United States, this one is the 3rd largest by planned enrollment of the 68 interventional ones that give a count, is one of 3 that started in 2018, is one of 56 with no phase, reaches primary completion later than 5 of the 20 other live ones, and was the 41st registered.

Bulimia Nervosa

173 studies on the registry are indexed under Bulimia Nervosa; 39 are open to participants now.

Browse Bulimia Nervosa studies →

Open to participants now

15 of the 87 studies in Bulimia Nervosa with a site in United States are open now. Recruiting first, the newest first:

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All 15 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 32 Bulimia Nervosa studies recruiting now, 9 (28%) set no upper age limit and 21 (66%) stop at 75 or younger; 15 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · healthy volunteers too.

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02

Study summary

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.

Read the detailed description

Specific Aim 1: To test on two study days, one neutral affect and one negative affect day (affect induction) whether negative affect alters brain reinforcement learning in a dopamine system anchored taste reward learning paradigm (a task for prediction error and reward value computation) during functional magnetic resonance brain imaging (fMRI). Hypothesis 1: In response to negative and compared to neutral affect induction, binge eating disorder (BED) and bulimia nervosa (BN) will show increased positive prediction error and taste valuation regression with striatum and insula activation compared to obese (OB) and healthy control (HC) groups. This will be an indication that negative affect excessively activates dopamine related reward circuit response in BED and BN. Specific Aim 2: To study during a food choice paradigm the effects of negative affect on brain circuitry for cognitive control and food valuation. Specific Aim 2a: To study brain circuitry for food valuation in response to neutral or negative affect. Hypothesis 2a: In response to negative and compared to neutral affect induction, BED and BN groups will show greater striatal activation when rating food for taste, compared to OB and HC. This will indicate that BED and BN are associated with increased affect-regulated motivation to approach high calorie foods after negative affect induction and compared to OB and HC. Specific Aim 2b: To study brain control circuitry during food choice in response to neutral or negative affect. Hypothesis 2b: In response to negative and compared to neutral affect induction, BED and BN groups will show increased insula and striatal, but lower dorsolateral prefrontal cortex (DLPFC) activation compared to OB and HC groups. This will indicate that negative affect activates automatic food reward circuit response, but reduces cognitive control circuitry during food choice in BED and BN. Specific Aim 3: To test whether brain activation predicts food intake or negative affect. Specific Aim 3a: To test whether brain activation can predict food intake during a post-fMRI scan test meal. Hypothesis 3a: On negative- versus neutral-affect days, BN and BED will select more food in a post-fMRI scan test meal; lower DLPFC and higher striatal activation during food choice, and higher (prediction error) taste reward activation in insula and ventral striatum will predict greater food intake. Specific Aim 3b: To test whether brain activation during reward learning or food choice predicts negative affect measured by EMA on the study day, as well as measured between study days in the individual's naturalistic environment. Hypothesis 3b: Insula, ventral striatum and DLPFC activation (taste prediction error task, food choice task) during the negative affect condition will predict the intensity of negative affect immediately after fMRI, as well as intensity of negative affect episodes during the days between brain scans in the individual's naturalistic environment, suggesting a neurobiological affective vulnerability.

03

Conditions studied

  • Bulimia Nervosa
  • Binge-Eating Disorder
  • Obesity
  • Eating Disorder

Keywords

  • fMRI
  • Reward
  • Food Choices
  • Negative Affect
04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
410 participants (estimated)

Study arms

  • Experimental
    Behavioral

    Negative Affect Task

    Behavioral: Negative Affect Task

Interventions

  • BehavioralNegative Affect Task

    fMRI stress task

    Also known as: Functional Magnetic Resonance Brain Imaging Stress Task

06

What researchers measure

Primary outcomes

  1. Taste Reward Brain Response to Negative Affect fMRI Task

    to study brain activation in a taste reward task in response to negative affect

    Time frame: 5 years

  2. Food Choice Brain Response to Negative Affect fMRI Task

    to study brain activation in a food choice task in response to negative affect

    Time frame: 5 years

  3. Brain Activation and Food Intake/negative Affect Relationships

    To test whether brain activation predicts food intake or negative affect

    Time frame: 5 years

07

Study locations

1 site
08

References and documents

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. PubMed 19631931 ↗
  • 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. PubMed 25808854 ↗
  • 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. PubMed 25961467 ↗
  • 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. PubMed 25865091 ↗
  • 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. PubMed 26893235 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2018 (actual). Primary completion is estimated for Jan 2027, 107 months after the start.

Of 63 non-industry interventional studies with no phase under Bulimia Nervosa, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 58. This study's planned 107 months is above that.

Counting every sponsor, half of 65 studies reached it within 43 months; a quarter within 18 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 28, 2017
First posted
Jan 8, 2018
StartActual
Feb 1, 2018
Primary completionEst.
Jan 2027
CompletionEst.
Jan 30, 2027
Last update
Aug 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03393039
Collaborators
Sanford Research, University of Colorado, Denver
Responsible party
Guido Frank (Professor, University of California, San Diego) — Principal investigator
First posted
Jan 8, 2018
Start date
Feb 1, 2018
Primary completion
Jan 2027 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Aug 3, 2026

Study contacts

Guido KW Frank, MD
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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