Bulimia NervosaNCT05995496
Changes in Inhibition and Valuation After Eating
A study testing Fasting state, Fed state and Magnetic Resonance Imaging in people with Bulimia Nervosa, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
An impaired ability to exert control has been implicated in bulimia nervosa (BN), but this impairment may not represent a stable trait or be the most effective focus for treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bulimia Nervosa
- What is being tested?
- Fasting state, Fed state and Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2023to 31 Dec 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Aged 18 to 45 years
- Current BMI greater than or equal to 18.5kg/m2 but under 30kg/m2
- Right-handed
- English-speaking
- Additional Inclusion Criteria for Women with Bulimia Nervosa:
- Meet DSM-5 criteria for bulimia nervosa
Who cannot join
- Medical instability
- Ongoing medical treatment, medical condition, or psychiatric disorder that may interfere with study variables or participation
- Shift work
- Pregnancy, planned pregnancy, or lactation during the study period
- Allergy to any of the ingredients in or unwillingness to consume the standardized meal or unwillingness to drink water during the fasting period
- Any contraindication for fMRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Jiulin Dai, B.S., 212-824-9561, jiulin.dai@mssm.edu
Riley Macks, (212) 824-9545, riley.macks@mssm.edu
About this study
Official title: Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa
An impaired ability to exert control has been implicated in bulimia nervosa (BN), but this impairment may not represent a stable trait or be the most effective focus for treatment. This project aims to understand how predictions and value-based decisions about control may be abnormally influenced by eating in individuals with BN, thereby maintaining cycles of binge eating, purging, and restriction.
Read the detailed description
The overarching goal of this project is to test a neurocomputational model of BN that incorporates learning and decision-making components of control. The study combines functional magnetic resonance imaging (fMRI), computational modeling, and real-time mobile assessments to examine the influences of acute fasting and eating on brain function and associated control-related updating and effort-valuation processes in BN. More specifically, the study has the following main objectives: 1) To determine the influence of eating on control-related prediction updating in BN.; 2) To determine the influence of eating on control-related cognitive effort valuation in BN; 3) To use state-specific neural activation to predict BN symptoms.
- Conditions
- Bulimia Nervosa
- Being tested
- Fasting state, Fed state, Magnetic Resonance Imaging
- Medical subject headings
- Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting stateOther
16 hours of fasting
Fed stateOther
Fed a standardized meal
Magnetic Resonance ImagingOther
Also called MRI
Neuroimaging with computational modeling
| Study group | Role | What they receive |
|---|---|---|
| Participants with Bulimia Nervosa | Experimental | Participants are randomly assigned (in even numbers across the two groups) to scan order:
A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.
B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day. Receives: Other: Fasting state; Other: Fed state; Other: Magnetic Resonance Imaging |
| Participants without Bulimia Nervosa | Active comparator | Participants are randomly assigned (in even numbers across the two groups) to scan order:
A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.
B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day. Receives: Other: Fasting state; Other: Fed state; Other: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors
Measured: 1-2.5 hours after a 16-hour fast (fasted state)
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors
Measured: 1-2.5 hours after a standardized meal (fed state)
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control
Measured: 1-2.5 hours after a 16-hour fast (fasted state)
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control
Measured: 1-2.5 hours after a standardized meal (fed state)
Secondary outcomes (7)
Percent correct responses to stop trials and the trial-by-trial association
Behavioral performance on the stop signal task, as measured by percent correct responses to stop trials and the trial-by-trial association between the predicted likelihood that upcoming inhibition is needed (P(stop)) from a Bayesian ideal observer model and accuracy
Measured: 1-2.5 hours after a 16-hour fast (fasted state)
Percent correct responses to stop trials and the trial-by-trial association
Behavioral performance on the stop signal task, as measured by percent correct responses to stop trials and the trial-by-trial association between the predicted likelihood that upcoming inhibition is needed (P(stop)) from a Bayesian ideal observer model and accuracy
Measured: 1-2.5 hours after a standardized meal (fed state)
Cognitive Effort Discounting Task Behavioral Performance
The subjective value of cognitive effort estimated for each N-back load level and cost- and benefit-modulated drift rate parameters from a drift- diffusion model applied to behavioral performance data
Measured: 1-2.5 hours after a 16-hour fast (fasted state)
Cognitive Effort Discounting Task Behavioral Performance
The subjective value of cognitive effort estimated for each N-back load level and cost- and benefit-modulated drift rate parameters from a drift- diffusion model applied to behavioral performance data
Measured: 1-2.5 hours after a standardized meal (fed state)
Binge-eating Severity
The frequency of binge-eating episodes as assessed by the Eating Disorder Examination (EDE) and Ecological Momentary Assessment (EMA). Binge-eating frequency has a minimum limit of 0 and no maximum limit. A higher score indicates a greater severity.
Measured: Baseline and 6-month follow-up
Compensatory Behavior Severity
The frequency of compensatory behaviors as assessed by the EDE and EMA. This frequency has a minimum limit of 0 and no maximum limit. A higher score indicates a greater severity.
Measured: Baseline and 6-month follow-up
Dietary Restriction Severity
The frequency of fasting episodes as assessed by the EDE avoidance of eating item (minimum limit = 0, maximum limit = 6); the severity of dietary restriction as assessed by the Eating Pathology Symptoms Inventory (EPSI) - restricting subscale (minimum limit=0; maximum limit=24), and the frequency of restrictive eating behaviors as assessed by EMA (minimum limit=0; no maximum limit). On all measures, a higher score indicates a greater severity.
Measured: Baseline and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start12 Dec 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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 Icahn School of Medicine at Mount SinaiThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two participant groups (one with and one without bulimia nervosa) will be scanned using MRI after they have fasted and after they have consumed a standardized meal. The order of these two scans will be counterbalanced across groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Laura Berner, Icahn School of Medicine at Mount Sinai
- Investigators
- Laura A Berner, Ph.D., Principal investigator, Mount Sinai Icahn School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995496
- Sponsor's protocol ID
- STUDY-22-01587
- Other IDs
- 1R01MH132786
- Status last verified
- Feb 2026
- First submitted
- 1 Aug 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa
- ClinicalTrials.gov ID
- NCT05995496
- Acronym / sponsor ID
- STUDY-22-01587
- Conditions
- Bulimia Nervosa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Aug 2023 (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.
An impaired ability to exert control has been implicated in bulimia nervosa (BN), but this impairment may not represent a stable trait or be the most effective focus for treatment. This project aims to understand how predictions and value-based decisions about control may be abnormally influenced by eating in individuals with BN, thereby maintaining cycles of binge eating, purging, and restriction.
Detailed description
The overarching goal of this project is to test a neurocomputational model of BN that incorporates learning and decision-making components of control. The study combines functional magnetic resonance imaging (fMRI), computational modeling, and real-time mobile assessments to examine the influences of acute fasting and eating on brain function and associated control-related updating and effort-valuation processes in BN. More specifically, the study has the following main objectives: 1) To determine the influence of eating on control-related prediction updating in BN.; 2) To determine the influence of eating on control-related cognitive effort valuation in BN; 3) To use state-specific neural activation to predict BN symptoms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two participant groups (one with and one without bulimia nervosa) will be scanned using MRI after they have fasted and after they have consumed a standardized meal. The order of these two scans will be counterbalanced across groups.
| Arm | Type | Receives |
|---|---|---|
| Participants with Bulimia Nervosa | Experimental | Other: Fasting state, Other: Fed state, Other: Magnetic Resonance ImagingParticipants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day. |
| Participants without Bulimia Nervosa | Active comparator | Other: Fasting state, Other: Fed state, Other: Magnetic Resonance ImagingParticipants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female
- Aged 18 to 45 years
- Current BMI greater than or equal to 18.5kg/m2 but under 30kg/m2
- Right-handed
- English-speaking
Key exclusion criteria (6 listed)
- Medical instability
- Ongoing medical treatment, medical condition, or psychiatric disorder that may interfere with study variables or participation
- Shift work
- Pregnancy, planned pregnancy, or lactation during the study period
- Allergy to any of the ingredients in or unwillingness to consume the standardized meal or unwillingness to drink water during the fasting period
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 |
|---|---|---|
| Fasting state16 hours of fasting | Other | Participants with Bulimia Nervosa, Participants without Bulimia Nervosa |
| Fed stateFed a standardized meal | Other | Participants with Bulimia Nervosa, Participants without Bulimia Nervosa |
| Magnetic Resonance ImagingAlso: MRINeuroimaging with computational modeling | Other | Participants with Bulimia Nervosa, Participants without Bulimia Nervosa |
Primary outcome
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
Time frame: 1-2.5 hours after a 16-hour fast (fasted state)
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
Time frame: 1-2.5 hours after a standardized meal (fed state)
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
Time frame: 1-2.5 hours after a 16-hour fast (fasted state)
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
Time frame: 1-2.5 hours after a standardized meal (fed state)
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control
7 secondary outcomes
Percent correct responses to stop trials and the trial-by-trial association
Time frame: 1-2.5 hours after a 16-hour fast (fasted state)
Percent correct responses to stop trials and the trial-by-trial association
Time frame: 1-2.5 hours after a standardized meal (fed state)
Cognitive Effort Discounting Task Behavioral Performance
Time frame: 1-2.5 hours after a 16-hour fast (fasted state)
Cognitive Effort Discounting Task Behavioral Performance
Time frame: 1-2.5 hours after a standardized meal (fed state)
Binge-eating Severity
Time frame: Baseline and 6-month follow-up
Compensatory Behavior Severity
Time frame: Baseline and 6-month follow-up
Dietary Restriction Severity
Time frame: Baseline and 6-month follow-up
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 17 Feb 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Bulimia Nervosa
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Naltrexone Neuroimaging in Teens With Eating Disorders
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Neurobiological and Psychological Maintenance Mechanisms Associated With Anticipatory Reward in Bulimia Nervosa
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Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization
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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.
Laura A Berner, Ph.D. principal investigator
Mount Sinai Icahn School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting state, Fed state and Magnetic Resonance Imaging in people with Bulimia Nervosa, run by Icahn School of Medicine at Mount Sinai 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Feb 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?
Contact Riley Macks, B.A. ((212) 824-9545, riley.macks@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task (time frame: 1-2.5 hours after a 16-hour fast (fasted state)). The study lists 4 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 17 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.