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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02997475
Recruitment Status : Active, not recruiting
First Posted : December 20, 2016
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
The Hilda & Preston Davis Foundation
Information provided by (Responsible Party):
Walter Kaye, University of California, San Diego

Study Description
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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).

Condition or disease
Bulimia Nervosa

Study Design
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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Neural Bases of Multiple Forms of Self-regulatory Control in Bulimia Nervosa
Study Start Date : June 2016
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2022
Groups and Cohorts
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Group/Cohort
Women with Bulimia Nervosa
Women Healthy Controls


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women (ages 18-35 years) with bulimia nervosa, and age- and BMI-matched healthy controls.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997475


Locations
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United States, California
UCSD Eating Disorders Center for Treatment and Research
San Diego, California, United States, 92121
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
The Hilda & Preston Davis Foundation
Investigators
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Study Director: Laura A. Berner, Ph.D. University of California, San Diego
More Information
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Responsible Party: Walter Kaye, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02997475    
Other Study ID Numbers: 151514
F32MH108311 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Keywords provided by Walter Kaye, University of California, San Diego:
Bulimia Nervosa
Bulimia
fMRI
Emotion Regulation
Response Inhibition
Additional relevant MeSH terms:
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Bulimia
Bulimia Nervosa
Hyperphagia
Signs and Symptoms, Digestive
 Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders