Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT02398318
Status:
WITHDRAWN
Last Update Posted:
2016-12-06
First Post:
2015-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
China Refractory Obsessive-Compulsive Disorder Deep Brain Stimulation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-10-18', 'releaseDate': '2022-12-25'}], 'estimatedResultsFirstSubmitDate': '2022-12-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'A pilot study is recruiting', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-04', 'studyFirstSubmitDate': '2015-01-23', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score', 'timeFrame': 'Baseline (preoperative), 6 months'}], 'secondaryOutcomes': [{'measure': 'Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score', 'timeFrame': 'Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months'}, {'measure': 'Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17, Beck Anxiety Scale, Beck Depression Scale-1 Score', 'timeFrame': 'Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months'}, {'measure': 'Change in Temperament and Character Inventory revised version (TCI-R) Score', 'timeFrame': 'Baseline (preoperative), 6 months, 24 months'}, {'measure': 'Iowa Gambling Task (change in task performance scores)', 'timeFrame': 'Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months'}, {'measure': 'Change in functional magnetic resonance imaging (fMRI) images', 'timeFrame': 'Baseline (preoperative), 2 weeks after last ERP session (average)'}, {'measure': 'Change in positron emission tomography (PET) brain glucose metabolism images', 'timeFrame': 'Baseline (preoperative), 6 months after surgery', 'description': 'Fluoro-D-glucose (FDG) will be utilized to evaluate cerebral metabolism at Baseline (preoperative) and 6 months.'}, {'measure': 'Quality of life: Global assessment of function', 'timeFrame': 'Baseline (preoperative), 2 weeks after last ERP session (average), 6 months after surgery, 24 months after surgery'}, {'measure': 'Disability: WHO disability assessment 2.0', 'timeFrame': 'Baseline (preoperative), 2 weeks after last ERP session (average), 6 months after surgery, 24 months after surgery'}, {'measure': 'Model Task (change in task performance scores)', 'timeFrame': 'Baseline (preoperative), 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['neurosurgery', 'deep brain stimulation', 'exposure response prevention'], 'conditions': ['Obsessive Compulsive Disorder']}, 'referencesModule': {'references': [{'pmid': '23443174', 'type': 'BACKGROUND', 'citation': 'Zuo C, Ma Y, Sun B, Peng S, Zhang H, Eidelberg D, Guan Y. Metabolic imaging of bilateral anterior capsulotomy in refractory obsessive compulsive disorder: an FDG PET study. J Cereb Blood Flow Metab. 2013 Jun;33(6):880-7. doi: 10.1038/jcbfm.2013.23. Epub 2013 Feb 27.'}, {'pmid': '22743198', 'type': 'BACKGROUND', 'citation': 'Wu H, Van Dyck-Lippens PJ, Santegoeds R, van Kuyck K, Gabriels L, Lin G, Pan G, Li Y, Li D, Zhan S, Sun B, Nuttin B. Deep-brain stimulation for anorexia nervosa. World Neurosurg. 2013 Sep-Oct;80(3-4):S29.e1-10. doi: 10.1016/j.wneu.2012.06.039. Epub 2012 Jun 25.'}, {'pmid': '37243560', 'type': 'DERIVED', 'citation': 'Xiong B, Li B, Wen R, Gao Y, Gong F, Li D, Xu Y, Deng H, Xiao L, Yin S, Zhang W, Lozano AM, Wang W. Use of differential stimulation of the nucleus accumbens and anterior limb of the internal capsule to improve outcomes of obsessive-compulsive disorder. J Neurosurg. 2023 May 26;139(5):1376-1385. doi: 10.3171/2023.4.JNS221824. Print 2023 Nov 1.'}], 'seeAlsoLinks': [{'url': 'http://www.mitoonet.com/rjh', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain stimulation (DBS) of the nucleus accumbens is the most tested therapeutic avenue for refractory OCD. However, large scale randomized controlled trials to evaluate the effectiveness of this approach are rare.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 60 years.\n2. A primary diagnosis of OCD, defined according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV).\n3. Chronic: disease duration of more than 5 years.\n4. Severity: a score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) of more than 25 or one subscale score of more than 15 ; a score for severity of illness on the Clinical Global Impression (CGI) scale of more than 4.\n5. Disability: a score on the Global Assessment Functioning (GAF) scale of less than 45.\n6. Refractory: a lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least three serotonin-reuptake inhibitors, one of which had to be clomipramine. Adequate behavior therapy, defined as 20 sessions of exposure and response prevention (ERP) with a therapist who has substantial expertise in OCD treatment.\n\nExclusion Criteria:\n\n1. Schizophrenic disorder; bipolar disorder; substance abuse or dependence (except for dependence on nicotine), as assessed with the use of the Mini-International Neuropsychiatric Interview (MINI 6.0.0).\n2. Cluster A or B personality disorder according to DSM-IV criteria, as assessed with the use of the Structured Clinical Interview II.\n3. A current severe major depressive episode, determined according to DSM-IV criteria (as assessed with the use of the MINI 6.0.0) and defined by the Hamilton Depression Rating Scale-17 (HAMD) score of more than 20 and a risk of suicide.\n4. Abnormal cognitive status (measured by MoCA), abnormal findings on functional magnetic resonance imaging (MRI) of the brain; and no contraindications to surgery or anesthesia.'}, 'identificationModule': {'nctId': 'NCT02398318', 'acronym': 'CRODS', 'briefTitle': 'China Refractory Obsessive-Compulsive Disorder Deep Brain Stimulation Study', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'China Refractory-Obsessive Compulsive Disorder Deep Brain Stimulation Study', 'orgStudyIdInfo': {'id': 'RCT-YY2015-CRODS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bilateral Nucleus Accumbens DBS', 'description': '6 month period of active bilateral nucleus accumbens DBS', 'interventionNames': ['Device: Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Bilateral Nucleus Accumbens DBS', 'description': '6 month period of sham bilateral nucleus accumbens DBS', 'interventionNames': ['Device: Sham Bilateral Nucleus Accumbens DBS']}], 'interventions': [{'name': 'Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)', 'type': 'DEVICE', 'otherNames': ['Active DBS'], 'description': 'High frequency stimulation applied using Suzhou Sceneray® DBS hardware (1120 electrode, 1180 (S) battery).', 'armGroupLabels': ['Bilateral Nucleus Accumbens DBS']}, {'name': 'Sham Bilateral Nucleus Accumbens DBS', 'type': 'DEVICE', 'otherNames': ['Sham DBS'], 'description': 'DBS system switched off.', 'armGroupLabels': ['Sham Bilateral Nucleus Accumbens DBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510370', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou psychiatric hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Bomin Sun, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Suzhou Sceneray Medical Co. , Ltd', 'class': 'INDUSTRY'}, {'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}, {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of functional neurosurgery department', 'investigatorFullName': 'Bomin Sun', 'investigatorAffiliation': 'Ruijin Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-12-25', 'type': 'RELEASE'}, {'date': '2023-10-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Bomin Sun, Director of functional neurosurgery department, Ruijin Hospital'}}}}