Bulimia NervosaNCT04917068
Neurobiological and Psychological Maintenance Mechanisms Associated With Anticipatory Reward in Bulimia Nervosa
An observational study of Bulimia Nervosa, run by University of Minnesota at 1 site in United States.
Trial summary
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). 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
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 30 Nov 2026
- Phase
- Observational
- 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
Study population: Adults with or without bulimia nervosa
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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.
- Conditions
- Bulimia Nervosa
- Medical subject headings
- Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Positive and Negative Affect Schedule (PANAS) self-reported negative affect
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.
Measured: 1-2 months
The Positive and Negative Affect Schedule (PANAS) self-reported positive affect
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.
Measured: 1-2 months
Activation in regions of the limbic threat network
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.
Measured: approximately 4 hours
Activation in regions of the striatal approach network
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.
Measured: approximately 4 hours
Frontolimbic connectivity
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.
Measured: approximately 4 hours
Frontostriatal connectivity
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.
Measured: approximately 4 hours
Secondary outcomes (1)
Duration of illness
Outcome is reported as the number of days participants in the bulimia nervosa group experience illness.
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 Apr 2022
- Primary completion11 Aug 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carol B Peterson, PhD, Principal investigator, University of Minnesota Department of Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917068
- Sponsor's protocol ID
- PSYCH-2020-28854
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological and Psychological Maintenance Mechanisms Associated With Anticipatory Reward in Bulimia Nervosa
- ClinicalTrials.gov ID
- NCT04917068
- Acronym / sponsor ID
- PSYCH-2020-28854
- Conditions
- Bulimia Nervosa
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 11 Aug 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 Jun 2021 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults with or without bulimia nervosa
Key inclusion criteria (9 listed)
- Right-handed
- Ability to read and speak in English
- 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
- No binge eating or purging episodes for the past three months on the EDE
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Activation in regions of the limbic threat 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 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.
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.
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.
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.
1 secondary outcome
Duration of illness
Time frame: 1-2 months
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 14 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Carol B Peterson, PhD principal investigator
University of Minnesota Department of Psychiatry and Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bulimia Nervosa, run by University of Minnesota 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 9 inclusion and 10 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 14 Sep 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?
The Positive and Negative Affect Schedule (PANAS) self-reported negative affect (time frame: 1-2 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.