Bulimia NervosaNCT03393039
Effects of Negative Affect in Individuals With Binge Eating Episodes
A study testing Negative Affect Task in people with Bulimia Nervosa and Binge-Eating Disorder, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bulimia Nervosa, Binge-Eating Disorder, Obesity
- What is being tested?
- Negative Affect Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 26Show fewer
- 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.
Who cannot join
- 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
Show all 32Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at San Diego
San Diego, California, 92121
About this study
Official title: 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.
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.
- Conditions
- Bulimia Nervosa, Binge-Eating Disorder, Obesity, Eating Disorder
- Being tested
- Negative Affect Task
- Keywords
- fMRI, Reward, Food Choices, Negative Affect
- Medical subject headings
- Bulimia Nervosa, Binge-Eating Disorder, Obesity, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Affect TaskBehavioural
Also called Functional Magnetic Resonance Brain Imaging Stress Task
fMRI stress task
| Study group | Role | What they receive |
|---|---|---|
| Behavioral | Experimental | Negative Affect Task Receives: Behavioral: Negative Affect Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste Reward Brain Response to Negative Affect fMRI Task
to study brain activation in a taste reward task in response to negative affect
Measured: 5 years
Food Choice Brain Response to Negative Affect fMRI Task
to study brain activation in a food choice task in response to negative affect
Measured: 5 years
Brain Activation and Food Intake/negative Affect Relationships
To test whether brain activation predicts food intake or negative affect
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Feb 2018
- Primary completionJan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Sanford Research, University of Colorado, Denver
- Responsible party
- Principal investigator, Guido Frank, University of California, San Diego
- Investigators
- Guido KW Frank, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393039
- Sponsor's protocol ID
- 16-2658
- Status last verified
- Jul 2026
- First submitted
- 28 Dec 2017
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 19631931Berg 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 25808854Pearson 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 25961467Racine 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 25865091Engel 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Effects of Negative Affect on Food Choices and Reward In Individuals With Binge Eating Episodes
- ClinicalTrials.gov ID
- NCT03393039
- Acronym / sponsor ID
- 16-2658
- Conditions
- Bulimia Nervosa, Binge-Eating Disorder, Obesity, Eating Disorder
- Keywords
- fMRI, Reward, Food Choices, Negative Affect
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Sanford Research, University of Colorado, Denver
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral | Experimental | Behavioral: Negative Affect TaskNegative Affect Task |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Affect TaskAlso: Functional Magnetic Resonance Brain Imaging Stress TaskfMRI stress task | Behavioural | Behavioral |
Primary outcome
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
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
Brain Activation and Food Intake/negative Affect Relationships
Time frame: 5 years
To test whether brain activation predicts food intake or negative affect
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 19631931Engel 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.
- Background: PubMed 25808854Berg 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.
- Background: PubMed 25961467Pearson 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.
- Background: PubMed 25865091Racine 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.
- Background: PubMed 26893235Engel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido KW Frank, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Affect Task in people with Bulimia Nervosa and Binge-Eating Disorder, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste Reward Brain Response to Negative Affect fMRI Task (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03393039, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.