Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT00325520
Status:
COMPLETED
Last Update Posted:
2014-08-15
First Post:
2006-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Neurocognitive Model of Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-14', 'studyFirstSubmitDate': '2006-05-12', 'studyFirstSubmitQcDate': '2006-05-12', 'lastUpdatePostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropsychological functioning', 'timeFrame': 'pre- and post-treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate thought processes and neural mechanisms that may contribute to the development of habitual behaviors. The investigators hypothesize that patients with AN will perform differently than people without eating disorders on a series of neuropsychological tasks and will show different neural activation patterns in functional neuroimaging scans.', 'detailedDescription': 'Patients with Anorexia Nervosa (AN) have extreme difficulty changing their eating behavior, even when they express desire for change. These behaviors seem to override all other potential responses, and can appear perseverative, or habitual. The purpose of this study is to investigate thought processes and neural mechanisms that may contribute to the development of habitual behaviors. The investigators hypothesize that patients with AN will perform differently than people without eating disorders on a series of neuropsychological tasks and will show different neural activation patterns in functional neuroimaging scans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Anorexia Nervosa or Healthy Volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion:\n\n* DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype), current or prior;\n* Age 16-45;\n* Inpatient on GCRU\n* Medically stable.\n\nExclusion:\n\n* Any other current major Axis I disorder (including current bulimia nervosa), except major depression;\n* History of concussion, seizure disorder, or other neurological illness;\n* History of learning disability;\n* Acute Suicidality\n\nHealthy comparison group:\n\nInclusion:\n\n* No current or past psychiatric illness;\n* Age 16-45\n* No history of binge eating or vomiting;\n* Normal weight (80%-120% ideal body weight)\n\nExclusion:\n\n* Significant medical or neurologic illness(concussion, seizure disorder, learning disability, other neurological illness)\n* Current psychotropic medication or medications known to impact cognition\n\nAdditional Exclusion Criteria for fMRI:\n\n* Significant Claustrophobia\n* Pregnancy\n* Indwelling metallic object, non-removable metal jewelry, medicinal patch or recent metallic ink tattoo\n* For patients, current psychotropic medications (antidepressants for 2 week (prozac and antipsychotics for 4 weeks)\n* For patients, any other current Axis I diagnosis'}, 'identificationModule': {'nctId': 'NCT00325520', 'briefTitle': 'A Neurocognitive Model of Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'A Neurocognitive Model of Anorexia Nervosa', 'orgStudyIdInfo': {'id': '#5984R'}, 'secondaryIdInfos': [{'id': 'K23MH076195-01A2', 'link': 'https://reporter.nih.gov/quickSearch/K23MH076195-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anorexia nervosa', 'description': 'Individuals with anorexia nervosa receiving inpatient treatment'}, {'label': 'Healthy controls'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joanna Steinglass, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York State Psychiatric Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Klarman Family Foundation', 'class': 'UNKNOWN'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}