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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00344656
Other study ID # #4850
Secondary ID
Status Completed
Phase N/A
First received June 23, 2006
Last updated April 18, 2012
Start date October 2004
Est. completion date October 2010

Study information

Verified date April 2012
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

This study will use functional magnetic resonance imaging to compare appetite-related brain activity in women with anorexia nervosa before and after receiving treatment for the disorder.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date October 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

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