NCT04917068 · University of Minnesota
Neurobiological and Psychological Maintenance Mechanisms Associated With Anticipatory Reward in Bulimia Nervosa
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 8, 2026 · Source of record for eligibility and locations