- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00344656
Appetite-Related Brain Activity in Women With Anorexia Nervosa
The Study of Appetite-Related Brain Activity With Functional Magnetic Resonance Imaging in Women With Anorexia Nervosa
Study Overview
Status
Conditions
Detailed Description
Anorexia nervosa (AN) is a serious eating disorder that is characterized by an extreme loss of appetite. People with AN view themselves as overweight and cannot bring themselves to eat, even though most are dangerously thin. Functional magnetic resonance imaging (fMRI) is a technique that can be used to determine which parts of the brain are activated by physical stimuli. When a certain stimulus is introduced, blood flow to the corresponding area of the brain increases. This increase in blood flow is depicted on the fMRI scan. A person with AN may have different responses to food when evaluated prior to treatment versus after treatment. This study will use fMRI to compare appetite-related brain activity in women with AN before and after receiving treatment for the disorder.
Participants in this study will undergo two fMRI scans. Participants with AN will have one scan before entering the "weight gain phase" of treatment for AN and another scan upon completion of treatment. Healthy volunteers will undergo scans during a similar time frame. Participants will not be allowed to eat from midnight on the night before the scan until after the fMRI procedure, but they may drink water. During the scan, participants will be shown various objects and real foods; they will also be asked to touch the objects and food with their eyes closed. Each visit will last approximately 45 minutes. Ear protectors will be provided to reduce scanner noise.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
For Participants with AN:
- DSM-IV diagnosis of AN (restricting or binge eating/purging subtype)
- Medically stable (not continuing to lose weight and vital signs stable)
For Healthy Participants:
- Currently weighs 80-120% of ideal weight
- no history of binge eating disorder or vomiting
- no current or past psychiatric illness
Exclusion Criteria:
For Participants with AN:
- Currently taking medication
- Current substance abuse or dependence disorder
- History of suicide attempt or other self-injurious behavior within 6 months prior to study entry
- Non-removable metal on or inside the body (e.g., metal pacemaker, surgical clips, metallic-ink tattoos)
For Healthy Participants:
- Current or past psychiatric illness
- History of binge eating or vomiting
- Any significant medical or neurologic illness
- Currently taking medication
- History of drug or alcohol abuse within 3 months prior to study entry
- Non-removable metal on or inside the body (e.g., metal pacemaker, surgical clips, metallic-ink tattoos)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Subjects and Controls
Patients with DSM-IV Anorexia Nervosa
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Collaborators and Investigators
Investigators
- Principal Investigator: Laurel Mayer, MD, New York State Psychiatric Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #4850
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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