Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT00344656
Status:
COMPLETED
Last Update Posted:
2012-04-19
First Post:
2006-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Appetite-Related Brain Activity in Women With Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-18', 'studyFirstSubmitDate': '2006-06-23', 'studyFirstSubmitQcDate': '2006-06-23', 'lastUpdatePostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Eating Disorders', 'Anorexia Nervosa'], 'conditions': ['Eating Disorders', 'Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with AN between 18 and 45 years of age hospitalized for treatment of anorexia nervosa.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor Participants with AN:\n\n* DSM-IV diagnosis of AN (restricting or binge eating/purging subtype)\n* Medically stable (not continuing to lose weight and vital signs stable)\n\nFor Healthy Participants:\n\n* Currently weighs 80-120% of ideal weight\n* no history of binge eating disorder or vomiting\n* no current or past psychiatric illness\n\nExclusion Criteria:\n\nFor Participants with AN:\n\n* Currently taking medication\n* Current substance abuse or dependence disorder\n* History of suicide attempt or other self-injurious behavior within 6 months prior to study entry\n* Non-removable metal on or inside the body (e.g., metal pacemaker, surgical clips, metallic-ink tattoos)\n\nFor Healthy Participants:\n\n* Current or past psychiatric illness\n* History of binge eating or vomiting\n* Any significant medical or neurologic illness\n* Currently taking medication\n* History of drug or alcohol abuse within 3 months prior to study entry\n* Non-removable metal on or inside the body (e.g., metal pacemaker, surgical clips, metallic-ink tattoos)'}, 'identificationModule': {'nctId': 'NCT00344656', 'briefTitle': 'Appetite-Related Brain Activity in Women With Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'The Study of Appetite-Related Brain Activity With Functional Magnetic Resonance Imaging in Women With Anorexia Nervosa', 'orgStudyIdInfo': {'id': '#4850'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects and Controls', 'description': 'Patients with DSM-IV Anorexia Nervosa'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Laurel Mayer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York State Psychiatric Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}