Neural Bases of Multiple Forms of Self-regulatory Control in Bulimia Nervosa (SRBN)

January 13, 2023 updated by: Walter Kaye, University of California, San Diego
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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92121
        • UCSD Eating Disorders Center for Treatment and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

General Inclusion Criteria:

  • 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)

General Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Women with Bulimia Nervosa
Women Healthy Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Regulatory Control
Time Frame: Day 2 (fMRI Scan)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goal-Directed Action Control
Time Frame: Day 1
An computerized instrumental learning task will be used to assess performance of women with and without bulimia nervosa.
Day 1
Eating Disorder Relevance
Time Frame: Day 0
The Eating Disorder Examination (EDE) will be conducted to assess relative associations of motor, affective, and goal-directed action control with bulimia nervosa severity.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Laura A. Berner, Ph.D., University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimate)

December 20, 2016

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 151514
  • F32MH108311 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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