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History of Changes for Study: NCT02997475
Neural Bases of Multiple Forms of Self-regulatory Control in Bulimia Nervosa (SRBN)
Latest version (submitted November 3, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 15, 2016 None (earliest Version on record)
2 October 12, 2018 Study Status and Outcome Measures
3 July 3, 2019 Study Status
4 October 1, 2019 Recruitment Status, Study Status and Contacts/Locations
5 November 3, 2020 Recruitment Status and Study Status
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Study NCT02997475
Submitted Date:  December 15, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 151514
Brief Title: Neural Bases of Multiple Forms of Self-regulatory Control in Bulimia Nervosa (SRBN)
Official Title: Neural Bases of Multiple Forms of Self-regulatory Control in Bulimia Nervosa
Secondary IDs: F32MH108311 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: December 2016
Overall Status: Recruiting
Study Start: June 2016
Primary Completion: May 2019 [Anticipated]
Study Completion:
First Submitted: October 25, 2016
First Submitted that
Met QC Criteria:
December 15, 2016
First Posted: December 20, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 15, 2016
Last Update Posted: December 20, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of California, San Diego
Responsible Party: Principal Investigator
Investigator: Walter Kaye
Official Title: Principal Investigator
Affiliation: University of California, San Diego
Collaborators: National Institute of Mental Health (NIMH)
The Hilda & Preston Davis Foundation
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Bulimia Nervosa
Keywords: Bulimia Nervosa
Bulimia
fMRI
Emotion Regulation
Response Inhibition
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Control
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 90 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Women with Bulimia Nervosa
Women Healthy Controls
Open or close this module Outcome Measures
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 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.
Open or close this module Eligibility
Study Population: Women (ages 18-35 years) with bulimia nervosa, and age- and BMI-matched healthy controls.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 35 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Central Contact Person: Joanna Chen
Telephone: (858) 534-8064
Email: jchen@ucsd.edu
Study Officials: Laura A. Berner, Ph.D.
Study Director
University of California, San Diego
Locations: United States, California
UCSD Eating Disorders Center for Treatment and Research
[Recruiting]
San Diego, California, United States, 92121
Contact:Contact: Joanna Chen 858-534-8064 jchen@ucsd.edu
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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