NCT06566612

Brief Summary

The purpose of this study is to investigate areas of the brain responsible for avoidance learning in adults with eating disorders using brain imaging techniques, computer tasks, and self-report questionnaires and interviews. The investigators will study changes in brain activity using a procedure called functional magnetic resonance imaging (fMRI). This study will include 78 women with an eating disorder (26 with anorexia nervosa \[AN\], 26 with bulimia nervosa \[BN\]) and 26 healthy controls (HC) aged 18-39. Aim 1: Evaluate behavioral differences in active and passive avoidance learning in eating disorders and associations with symptoms. Aim 2: Evaluate whether corticostriatal and limbic-prefrontal fMRI BOLD response associated with avoidance learning differs in eating disorders relative to healthy controls and relates to symptoms. Aim 3: Evaluate whether functional connectivity of avoidance learning neural circuity differs in eating disorders relative to healthy controls.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Aug 2024

Typical duration 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 Progress62%
Aug 2024Jul 2027

Study Start

First participant enrolled

August 1, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

August 15, 2024

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Learning rate

    Behavioral responses during a card game gambling task

    25 minutes

  • fMRI brain response

    fMRI brain activity associated with the card game gambling task

    25 minutes

  • Brain connectivity

    Whole-brain functional connectivity associated with the card game gambling task

    10 minutes

Study Arms (3)

Anorexia Nervosa

Participants that meet Diagnostic And Statistical Manual Of Mental Disorders (DSM-V) criteria for Anorexia Nervosa.

Bulimia Nervosa

Participants that meet DSM-V criteria for Bulimia Nervosa.

Healthy Controls

Participants that do not meet DSM-V criteria for any disorder.

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will recruit 52 adult women currently ill with an eating disorder, including anorexia nervosa (AN; n=26) and bulimia nervosa (BN, n=26), and 26 healthy control (HC) women between the ages of 18 and 39.

You may qualify if:

  • Eating Disorder Group:
  • Between the ages of 18 and 39 years old
  • Meet DSM-V criteria for anorexia nervosa or bulimia nervosa
  • Healthy Controls:
  • Between the ages of 18 and 39 years old
  • Have maintained 85% to 120% ideal body weight since menarche

You may not qualify if:

  • Psychotic illness/other mental illness requiring hospitalization
  • Current dependence on drugs or alcohol defined by DSM IV criteria. Additionally, positive test results for drug use on the day of the scan, apart of marijuana, will result in cancelling or rescheduling the scan because acute use will impact MRI measures.
  • Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
  • Neurological disorder, neurodevelopmental disorder, or history of head injury with \>30 min loss of consciousness
  • Any contraindication to undergoing an MRI
  • Primary obsessive compulsive disorder or primary major depressive disorder
  • If taking other psychotropic medication, any change in dosage in the 2 weeks before scanning
  • Meet criteria for the diagnosis of any psychiatric disorder currently
  • Any history of binge eating or purging behaviors, including self-induced vomiting, laxative or diuretic misuse
  • Use of any psychoactive or other medication known to affect mood or concentration in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Eating Disorders Treatment and Research Program

La Jolla, California, 92121, United States

RECRUITING

MeSH Terms

Conditions

Bulimia NervosaAnorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Central Study Contacts

Christina E Wierenga, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Residence

Study Record Dates

First Submitted

August 15, 2024

First Posted

August 22, 2024

Study Start

August 1, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations