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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

Tracking Information
First Submitted Date October 25, 2016
First Posted Date December 20, 2016
Last Update Posted Date October 3, 2019
Study Start Date June 2016
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 12, 2018)
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)
Original Primary Outcome Measures
 (submitted: December 15, 2016)
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 BN
Change History Complete list of historical versions of study NCT02997475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 15, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neural Bases of Multiple Forms of Self-regulatory Control in Bulimia Nervosa
Official Title Neural Bases of Multiple Forms of Self-regulatory Control in Bulimia Nervosa
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women (ages 18-35 years) with bulimia nervosa, and age- and BMI-matched healthy controls.
Condition Bulimia Nervosa
Intervention Not Provided
Study Groups/Cohorts
  • Women with Bulimia Nervosa
  • Women Healthy Controls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: December 15, 2016)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2022
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02997475
Other Study ID Numbers 151514
F32MH108311 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Walter Kaye, University of California, San Diego
Study Sponsor University of California, San Diego
Collaborators
  • National Institute of Mental Health (NIMH)
  • The Hilda & Preston Davis Foundation
Investigators
Study Director: Laura A. Berner, Ph.D. University of California, San Diego
PRS Account University of California, San Diego
Verification Date October 2019