- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02997475
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
-
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California
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San Diego, California, United States, 92121
- UCSD Eating Disorders Center for Treatment and Research
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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 |
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Women with Bulimia Nervosa
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Women Healthy Controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Regulatory Control
Time Frame: Day 2 (fMRI Scan)
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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)
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Day 2 (fMRI Scan)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goal-Directed Action Control
Time Frame: Day 1
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An computerized instrumental learning task will be used to assess performance of women with and without bulimia nervosa.
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Day 1
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Eating Disorder Relevance
Time Frame: Day 0
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The Eating Disorder Examination (EDE) will be conducted to assess relative associations of motor, affective, and goal-directed action control with bulimia nervosa severity.
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Day 0
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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
Additional Relevant MeSH Terms
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.
Clinical Trials on Bulimia Nervosa
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University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
-
Yeshiva UniversityYale UniversityRecruitingAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
-
Linnaeus UniversityGöteborg University; Linkoeping UniversityRecruitingBulimia Nervosa | Major Depression | Anorexia Nervosa/BulimiaSweden
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University Hospital, ToulouseUnknownAnorexia Nervosa/BulimiaFrance
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Maastricht UniversityZonMw: The Netherlands Organisation for Health Research and Development; Utrecht... and other collaboratorsRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa (Other Specified Eating Disorder) | Atypical Bulimia Nervosa (Other Specified Eating Disorder)Netherlands
-
Washington University School of MedicineNational Institute of Mental Health (NIMH)Completed
-
Rosemary Claire RodenChildren's Miracle NetworkEnrolling by invitationBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
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University Health Network, TorontoKlarman Family FoundationCompletedAnorexia Nervosa | Bulimia Nervosa
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Drexel UniversityNational Institute of Mental Health (NIMH)Active, not recruitingBinge-Eating Disorder | Bulimia Nervosa | Binge Eating | Bulimia; Atypical | Binge-Eating and Purging Type Anorexia NervosaUnited States
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University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia NervosaUnited States