NCT02997475

Brief Summary

The purpose of this study is to investigate areas of the brain responsible for self-regulation in adult women who have never had an eating disorder with women who have bulimia nervosa. More specifically, investigators are interested in changes in brain activation (e.g., changes in blood flow and oxygen use) when inhibiting responses and regulating emotions. Data collection will rely on a technology called functional magnetic resonance imaging (fMRI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

6.2 years

First QC Date

October 25, 2016

Last Update Submit

January 13, 2023

Conditions

Keywords

Bulimia NervosaBulimiafMRIEmotion RegulationResponse Inhibition

Outcome Measures

Primary Outcomes (1)

  • Self-Regulatory Control

    Functional Magnetic Resonance Imaging will be used to assess brain activation associated with motor inhibitory control and affect regulation in women with bulimia nervosa (BN)

    Day 2 (fMRI Scan)

Secondary Outcomes (2)

  • Goal-Directed Action Control

    Day 1

  • Eating Disorder Relevance

    Day 0

Study Arms (2)

Women with Bulimia Nervosa

Women Healthy Controls

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women (ages 18-35 years) with bulimia nervosa, and age- and BMI-matched healthy controls.

You may qualify if:

  • Female
  • Right-handed
  • Between the ages of 18 and 35 years
  • \*For Women with Bulimia Nervosa:
  • Binge eating (i.e., eating a large amount of food while experiencing a sense of loss of control)
  • Purging via self-induced vomiting (other methods may also be endorsed)

You may not qualify if:

  • Current significant medical illness or condition (e.g., diabetes, thyroid disease)
  • Pregnancy, planned pregnancy, or lactation during the study period
  • Non-removable metallic objects in the body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Eating Disorders Center for Treatment and Research

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Bulimia NervosaBulimiaEmotional Regulation

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsSelf-ControlSocial BehaviorBehavior

Study Officials

  • Laura A. Berner, Ph.D.

    University of California, San Diego

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2016

First Posted

December 20, 2016

Study Start

June 1, 2016

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Locations