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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02997475
Other study ID # 151514
Secondary ID F32MH108311
Status Completed
Phase
First received
Last updated
Start date June 2016
Est. completion date July 31, 2022

Study information

Verified date January 2023
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States UCSD Eating Disorders Center for Treatment and Research San Diego California

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Diego National Institute of Mental Health (NIMH), The Hilda & Preston Davis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-Regulatory Control 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 Goal-Directed Action Control An computerized instrumental learning task will be used to assess performance of women with and without bulimia nervosa. Day 1
Secondary Eating Disorder Relevance 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
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