Neurobiology of Anorexia and Bulimia Nervosa
1 other identifier
interventional
150
1 country
1
Brief Summary
The purpose of this study is to investigate areas of the brain responsible for appetite regulation. More specifically, the investigators would like to study changes in brain activation, e.g., changes in blood flow and oxygen use of the brain, during two different states: Once when the participants are hungry, and once when the participants are not hungry. The aim is to find out more about the neurobiology of Anorexia and Bulimia Nervosa by comparing women who never had an eating disorder with women who have recovered from Anorexia or Bulimia Nervosa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Posted
Study publicly available on registry
November 12, 2020
CompletedNovember 12, 2020
November 1, 2020
5.1 years
February 23, 2009
November 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Anterior insula (AI) and orbital frontal cortex (OFC) response to sucrose(relative to ionic water)
fMRI BOLD response
5 years
Study Arms (2)
1
EXPERIMENTALPeriod of 12 hours where participants eat regulated meals
2
EXPERIMENTALPeriod of 12 hours where participants do not eat anything
Interventions
hungry state - refrain from eating after lunch at 12 noon until 9 a.m. the next morning
Eligibility Criteria
You may qualify if:
- Must have had a DSM-IV diagnosis of anorexia or bulimia nervosa
- The onset of their illness must have been at least 4 years prior to participating in this study
- Must have recovered for 12 months or more prior to entering the study.
You may not qualify if:
- Met diagnosis of alcohol or drug abuse or dependence in the 3 months prior to the study.
- Current diagnosis of a severe major affective or anxiety disorder or presence of other psychopathology that might interfere with ability to participate in the study.
- Organic brain syndromes, dementia, psychotic disorders or mental retardation
- Neurological or medical disorders
- Use of psychoactive medication in the 3 months prior to the study.
- Pregnancy or lactation, lack of effective birth control during 15 days before the scans.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSD General Clinical Research Center
San Diego, California, 92103, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Kaye, M.D.
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 23, 2009
First Posted
November 12, 2020
Study Start
February 1, 2009
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
November 12, 2020
Record last verified: 2020-11