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

Bulimia Nervosa Clinical Trial

— SRBN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997475
• Other study ID #: 151514
• Secondary ID: F32MH108311
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa

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