- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04917068
Neurobiological and Psychological Maintenance Mechanisms Associated With Anticipatory Reward in Bulimia Nervosa
January 5, 2026 updated by: University of Minnesota
The purpose of this investigation is to identify the potentially crucial role of anticipatory reward mechanisms maintaining bulimic behavior (i.e., binge eating and purging) in bulimia nervosa (BN).
The research will investigate neural and psychological anticipatory processes in BN, both in the scanner and the natural environment.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Bulimia nervosa (BN), an eating disorder characterized by recurrent bulimic episodes of binge eating and often persists in spite of treatment, likely indicating ineffectively targeted maintenance mechanisms.
Treatment outcome data suggest that < 30-45% of adults who receive treatment for BN exhibit prolonged remission.
Further, BN is often characterized by a worsening course in which symptom severity increases with duration of illness.
Intervention advances require identification of both the mechanisms that underlie reward derived from bulimic behavior and the mechanisms that maintain these behaviors over time.
Current treatments for BN focus on immediate antecedents and consequences of bulimic behavior, despite the possibility that the reward derived from these behaviors may occur well before this point during the anticipation of binge eating and purging.
A majority (>75%) of individuals with BN report "planning" some or most of their bulimic episodes.
Thus, determining the role of reward anticipation in BN will facilitate the application of novel interventions that more precisely target these neglected mechanisms.
Further, research indicates that reward mechanisms become increasingly focused on anticipation in later phases of reward learning.
Therefore, it is important to determine how reward anticipation processes contribute to the maintenance of bulimic behaviors and interact with illness duration to facilitate BN chronicity.
The purpose of this investigation is to identify the potentially crucial role of anticipatory reward mechanisms maintaining bulimic behavior (i.e., binge eating and purging) in bulimia nervosa (BN).
The research will investigate neural and psychological anticipatory processes in BN, both in the scanner and the natural environment.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carol B Peterson, PhD
- Phone Number: (612)-273-9811
- Email: peter161@umn.edu
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
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Contact:
- Carol B Peterson, PhD
- Phone Number: 612-273-9811
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Adults with or without bulimia nervosa
Description
Inclusion Criteria:
Bulimia nervosa (BN) and healthy control (HC) groups:
- Right-handed
- Ability to read and speak in English
BN group only:
- Eating Disorder Examination (EDE) diagnosis of BN (i.e., at least one objective bulimic episode and one self-induced vomiting episode per week for at three months) with binge episodes always accompanied by self-induced vomiting
- Stable dose for at least 6 weeks of any recent changes in medication impacting mood, appetite, or weight
HC group only:
- No binge eating or purging episodes for the past three months on the EDE
- No current or past history of an eating disorder as diagnosed by Structured Clinical Interview for DSM-5 Disorders
Exclusion Criteria:
- History of gastric bypass surgery
- Medical condition acutely affecting eating behavior and/or weight (i.e., pregnancy, lactation, thyroid disease)
- Current medical or psychiatric instability (i.e., hospitalization required in the past three months)
- Lifetime history of psychosis or bipolar disorder
- History of neurological disorder or injury (i.e., stoke, head injury with >10 minutes loss of consciousness)
- Current substance use disorder
- BMI less than 19 kg/m^2
- Acute suicidality requiring hospitalization
- fMRI exclusions as specifiedd by the Center for Magnetic Resonance Research
- Food allergy that cannot be accommodated through substitutions to the laboratory test snack
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Bulimia Nervosa
Participants with diagnosed bulimia nervosa (BN) who will complete all tasks during Visits 1 and 2 in addition to ecological momentary assessment (EMA) procedures following Visit 2.
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Healthy Control
Participants without diagnosed BN or other current or past eating disorders who will complete all tasks during Visits 1 and 2 and will not complete EMA procedures following Visit 2.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Positive and Negative Affect Schedule (PANAS) self-reported negative affect
Time Frame: 1-2 months
|
The Positive and Negative Affect Schedule (PANAS) is a self-report measure comprising two scales, one of which we will use to assess participants' negative affect.
The scale includes ten Likert-style items, which participants rate from 1 = not at all to 5 = very much.
Composite scores range from 10-50, and a score of 50 indicates greater negative affect.
The PANAS will be administered to measure emotion at multiple times during the second visit as well as during EMA administration and to establish a baseline at the first visit.
|
1-2 months
|
|
The Positive and Negative Affect Schedule (PANAS) self-reported positive affect
Time Frame: 1-2 months
|
The Positive and Negative Affect Schedule (PANAS) is a self-report measure comprising two scales, one of which we will use to assess participants' positive affect.
The scale includes ten Likert-style items, which participants rate from 1 = not at all to 5 = very much.
Composite scores range from 10-50, and a score of 50 indicates greater positive affect.
The PANAS will be administered to measure emotion at multiple times during the second visit as well as during EMA administration and to establish a baseline at the first visit.
|
1-2 months
|
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Activation in regions of the limbic threat network
Time Frame: approximately 4 hours
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fMRI will be used to assess the neural correlates of bulimic behavior anticipation.
Outcome is reported as the mean z-scores from voxels in limbic regions (amygdala, hippocampus, insula) extracted from a 2x2 analysis of the BED versus HC groups in the food choice versus shopping contrast results of the fMRI task regression analysis.
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approximately 4 hours
|
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Activation in regions of the striatal approach network
Time Frame: approximately 4 hours
|
fMRI will be used to assess the neural correlates of bulimic behavior anticipation.
Outcome is reported as the mean z-scores from voxels in striatal regions (nucleus accumbens, caudate and putamen) extracted from a 2x2 analysis of the BED versus HC groups the food choice versus shopping contrast results of the fMRI task regression analysis.
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approximately 4 hours
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Frontolimbic connectivity
Time Frame: approximately 4 hours
|
fMRI will be used to assess the neural correlates of bulimic behavior anticipation.
Outcome is reported as the cross-correlation between the BOLD signal time series from fronto-limbic regions of interest (amygdala, hippocampus, insula, anterior cingulate cortex, medial prefrontal cortex) contrasted between food choice versus shopping tasks.
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approximately 4 hours
|
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Frontostriatal connectivity
Time Frame: approximately 4 hours
|
fMRI will be used to assess the neural correlates of bulimic behavior anticipation.
Outcome is reported as the cross-correlation between the BOLD signal time series from fronto-striatal regions of interest (caudate, putamen, insula, nucleus accumbens, orbitofrontal cortex) contrasted between food choice versus shopping tasks.
|
approximately 4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of illness
Time Frame: 1-2 months
|
Outcome is reported as the number of days participants in the bulimia nervosa group experience illness.
|
1-2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carol B Peterson, PhD, University of Minnesota Department of Psychiatry and Behavioral Sciences
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 Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
November 30, 2026
Study Registration Dates
First Submitted
June 1, 2021
First Submitted That Met QC Criteria
June 1, 2021
First Posted (Actual)
June 8, 2021
Study Record Updates
Last Update Posted (Estimated)
January 8, 2026
Last Update Submitted That Met QC Criteria
January 5, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSYCH-2020-28854
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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