NCT04917068

Brief 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). The research will investigate neural and psychological anticipatory processes in BN, both in the scanner and the natural environment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Apr 2022Nov 2026

First Submitted

Initial submission to the registry

June 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

4.7 years

First QC Date

June 1, 2021

Last Update Submit

January 5, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    approximately 4 hours

Secondary Outcomes (1)

  • Duration of illness

    1-2 months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults with or without bulimia nervosa

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Food allergy that cannot be accommodated through substitutions to the laboratory test snack

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Bulimia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Carol B Peterson, PhD

    University of Minnesota Department of Psychiatry and Behavioral Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol B Peterson, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 8, 2021

Study Start

April 1, 2022

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations