Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2026-01-19 @ 12:13 PM
Study NCT ID:
NCT02593695
Status:
UNKNOWN
Last Update Posted:
2015-11-10
First Post:
2015-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}, {'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-09', 'studyFirstSubmitDate': '2015-10-14', 'studyFirstSubmitQcDate': '2015-10-30', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI', 'timeFrame': '6 month'}], 'secondaryOutcomes': [{'measure': 'weight', 'timeFrame': '6 month'}, {'measure': 'Yale-Brown Obsessive Compulsive Scale', 'timeFrame': '6 month', 'description': 'Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.'}, {'measure': 'Self-Rating Depression Scale', 'timeFrame': '6 month', 'description': 'Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.'}, {'measure': 'The Symptom Checklist-90', 'timeFrame': '6 month', 'description': 'The Symptom Checklist-90(SCL-90) is used to evaluate general status.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anorexia Nervosa', 'Deep Brain Stimulation', 'Nucleus accumbens'], 'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'Anorexia nervosa (AN) is a complex and severe psychiatric disorder with high relapse rates under standard treatment.Deep brain stimulation (DBS) may be a novel treatment in severe Anorexia nervosa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 65 years of age, male or female patients.\n2. Diagnosis is Anorexia Nervosa(AN) by the DSMIV(Diagnostic and Statistical Manual of Mental Disorders Fourth Edition).\n3. BMI\\<16.\n4. Long-term pharmacotherapy resistance.\n5. Written informed consent.\n6. normal intelligence and compliance\n\nExclusion Criteria:\n\n1. Surgical contradiction（implanted artificial cochlea、cardiac pacemaker、cardiac defibrillator、stereotactic ablative surgery、DBS）or receive other surgery which may influence this time of surgery in half year, or other neurosurgical contradictions； History of brain trauma；\n2. History of severe neuropsychiatric disease；\n3. Epilepsy；\n4. severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension；\n5. Severe diabetes ,severe cardiovascular and cerebrovascular disease；\n6. Malignant tumor；\n7. Being using anticoagulant or showing clinical hemorrhagic tendency； Pregnant female；\n8. Patients are taking part in other clinical trials in recent 3months； Being deem as unfit for the trials by researcher'}, 'identificationModule': {'nctId': 'NCT02593695', 'briefTitle': 'Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Treat Severe Anorexia Nervosa', 'orgStudyIdInfo': {'id': 'ANDBS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deep Brain Stimulation', 'description': 'Continuous deep brain stimulation of bilateral nucleus accumbens', 'interventionNames': ['Procedure: Deep brain stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Control', 'description': 'Fluoxetine', 'interventionNames': ['Other: Fluoxetine']}], 'interventions': [{'name': 'Deep brain stimulation', 'type': 'PROCEDURE', 'otherNames': ['DBS'], 'description': 'Deep brain stimulation of bilateral nucleus accumbens', 'armGroupLabels': ['Deep Brain Stimulation']}, {'name': 'Fluoxetine', 'type': 'OTHER', 'description': 'Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).', 'armGroupLabels': ['Standard Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710038', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Department of neurosurgery, Tangdu Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Guo-dong Gao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of neurosurgery, Tangdu Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurosurgery Department', 'investigatorFullName': 'Guodong Gao', 'investigatorAffiliation': 'Tang-Du Hospital'}}}}