Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-22 @ 12:55 PM
Study NCT ID:
NCT04409457
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2020-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-Control in Bulimia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-20', 'releaseDate': '2025-11-05'}, {'releaseDate': '2025-12-19'}], 'estimatedResultsFirstSubmitDate': '2025-11-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D052018', 'term': 'Bulimia Nervosa'}, {'id': 'D002032', 'term': 'Bulimia'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Two participant groups (one with and one without bulimia nervosa) will be scanned using MRI after they have fasted and after they have consumed a standardized meal. The order of these two scans will be counterbalanced across groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-05-26', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'P(stop) at fasting state', 'timeFrame': 'at 16 hours after fast', 'description': 'Frontostriatal activation associated with the predicted likelihood that upcoming inhibition is needed (P(stop))'}, {'measure': 'Prediction errors at fasting state', 'timeFrame': 'at 16 hours after fast', 'description': 'Frontostriatal activation associated with: inhibitory control prediction errors (signed and unsigned)'}, {'measure': 'Successful inhibition at fasting state', 'timeFrame': 'at 16 hours after fast', 'description': 'Frontostriatal activation associated with successful inhibition'}, {'measure': 'P(stop) at fed state', 'timeFrame': 'at 30 minutes after a standardized meal', 'description': 'Frontostriatal activation associated with the predicted likelihood that upcoming inhibition is needed (P(stop))'}, {'measure': 'Prediction errors at fed state', 'timeFrame': 'at 30 minutes after a standardized meal', 'description': 'Frontostriatal activation associated with inhibitory control prediction errors (signed and unsigned)'}, {'measure': 'Successful inhibition at fed state', 'timeFrame': 'at 30 minutes after a standardized meal', 'description': 'Frontostriatal activation associated with successful inhibition'}], 'secondaryOutcomes': [{'measure': 'Stop Signal Reaction Time (SSRT) at fasting state', 'timeFrame': 'at 16 hours after fast', 'description': 'Behavioral performance on the stop signal task, as measured by stop signal reaction time'}, {'measure': 'Stop Signal Reaction Time (SSRT) at fed state', 'timeFrame': 'at 30 minutes after a standardized meal', 'description': 'Behavioral performance on the stop signal task, as measured by stop signal reaction time'}, {'measure': 'Stop Signal Task Performance at fasting state', 'timeFrame': 'at 16 hours after fast', 'description': 'Percent correct responses to stop trial on Stop Signal Task Performance'}, {'measure': 'Stop Signal Task Performance at fed state', 'timeFrame': 'at 30 minutes after a standardized meal', 'description': 'Percent correct responses to stop trial on Stop Signal Task Performance'}, {'measure': 'Frequency of Eating Disorder Symptom Episodes', 'timeFrame': 'Baseline (At study screening)', 'description': 'The frequency of binge eating episodes, self-induced vomiting episodes, and fasting episodes as assessed by the Eating Disorder Examination (EDE). Frequency of episodes assessed with no minimum or maximum limit.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bulimia nervosa', 'binge eating', 'purging', 'fasting', 'eating disorder', 'control'], 'conditions': ['Bulimia Nervosa']}, 'descriptionModule': {'briefSummary': 'This study examines the influence of acute fasting and eating on self-control in adult females with and without bulimia nervosa (BN). Specifically, the study team is investigating whether differences in behavior and brain activation in response to computer tasks after fasting and after eating a meal could help to explain the symptoms of bulimia nervosa. Data will be collected using questionnaires and a technology called magnetic resonance imaging (MRI).', 'detailedDescription': 'Treatment-resistant binge eating and purging may be perpetuated by self-control deficits linked to reduced activation in frontostriatal circuits. To date, however, neurocognitive studies of BN have not assessed the dynamic computational processes underlying inhibition or considered the fact that individuals with BN oscillate between two extremes-under-controlled and over-controlled intake. The proposed study combines neuroimaging with computational modeling to investigate the influences of acute fasting and eating (i.e., metabolic states) on how the brains of women with bulimia nervosa (BN) adaptively prepare for and exert inhibitory control. More specifically, the study has the following main objectives: 1) To determine whether eating and fasting affect adaptive inhibitory control and related frontostriatal activation abnormally in BN; 2) To identify associations of BN severity with state-specific frontostriatal activation and behavior.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The prevalence of bulimia nervosa is substantially greater in women than in men. Moreover, prior research suggest that men and women show different neural response patterns during the engagement of inhibitory control, and that satiety differentially impacts the neural function of men and women.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Aged 18 to 35 years\n* Currently between 85 and 130% of the expected weight for height\n* Right-handed\n* English-speaking\n\nAdditional Inclusion Criteria for Women with Bulimia Nervosa:\n\n° Meet DSM-5 criteria for bulimia nervosa\n\nExclusion Criteria:\n\n* Medical instability\n* Ongoing medical treatment, medical condition, or psychiatric disorder that may interfere with study variables or participation\n* Shift work\n* Pregnancy, planned pregnancy, or lactation during the study period\n* Allergy to any of the ingredients in or unwillingness to consume the standardized meal or unwillingness to drink water during the fasting period\n* Any contraindication for fMRI'}, 'identificationModule': {'nctId': 'NCT04409457', 'briefTitle': 'Self-Control in Bulimia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'The Influences of Eating and Fasting on Inhibitory Control in Bulimia Nervosa: A Computational Neuroimaging Study', 'orgStudyIdInfo': {'id': 'GCO 19-1047'}, 'secondaryIdInfos': [{'id': 'K23MH118418', 'link': 'https://reporter.nih.gov/quickSearch/K23MH118418', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Participants with Bulimia Nervosa', 'description': 'Participants are randomly assigned (in even numbers across the two groups) to scan order:\n\nA. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.\n\nB. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.', 'interventionNames': ['Other: fasting state', 'Other: fed state', 'Other: magnetic resonance imaging']}, {'type': 'OTHER', 'label': 'Participants without Bulimia Nervosa', 'description': 'Participants are randomly assigned (in even numbers across the two groups) to scan order:\n\nA. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.\n\nB. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.', 'interventionNames': ['Other: fasting state', 'Other: fed state', 'Other: magnetic resonance imaging']}], 'interventions': [{'name': 'fasting state', 'type': 'OTHER', 'description': '16 hours of fasting', 'armGroupLabels': ['Participants with Bulimia Nervosa', 'Participants without Bulimia Nervosa']}, {'name': 'fed state', 'type': 'OTHER', 'description': 'fed a standardized meal', 'armGroupLabels': ['Participants with Bulimia Nervosa', 'Participants without Bulimia Nervosa']}, {'name': 'magnetic resonance imaging', 'type': 'OTHER', 'otherNames': ['MRI'], 'description': 'neuroimaging with computational modeling', 'armGroupLabels': ['Participants with Bulimia Nervosa', 'Participants without Bulimia Nervosa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Laura A Berner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'Beginning 24 months following peer-reviewed article publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychiatry', 'investigatorFullName': 'Laura Berner', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-05', 'type': 'RELEASE'}, {'date': '2025-11-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Laura Berner, Associate Professor of Psychiatry, Icahn School of Medicine at Mount Sinai'}}}}