Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-17 @ 2:25 PM
Study NCT ID:
NCT01370304
Status:
UNKNOWN
Last Update Posted:
2012-02-15
First Post:
2011-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation Compared or Associated With Venlafaxine for Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-13', 'studyFirstSubmitDate': '2011-06-08', 'studyFirstSubmitQcDate': '2011-06-08', 'lastUpdatePostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure is remission', 'timeFrame': '1-6 weeks', 'description': 'It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 \\< 8)'}], 'secondaryOutcomes': [{'measure': 'fMRI', 'timeFrame': '0,6 weeks'}, {'measure': 'CGI', 'timeFrame': '1-6 weeks', 'description': 'Using the Clinical Global Impression scale(CGI)'}, {'measure': 'QIDS-C30', 'timeFrame': '1-6 weeks'}, {'measure': 'UKU Scale', 'timeFrame': '1-6 weeks', 'description': 'Side effects will be assessed using the UKU Scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['repetitive Transcranial Magnetic Stimulation (rTMS)', 'Depression', 'Venlafaxine', 'fMRI'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to treat participants with a diagnosis of depressive disorder to assess the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of depressive disorders compared venlafaxine only (the optimal medication) and to rTMS only. fMRI will be performed to determine if treatment response is related to changes in fMRI, and use it to investigate the respondence to the treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* Clinical diagnosis of major depressive disorder (DSM-IV)\n* HDRS-17 items \\> 20\n* Failure of one antidepressant treatment (efficacious doses for 6 weeks at least)\n\nExclusion Criteria:\n\n* Psychotic features\n* Failure of one previous venlafaxine treatment\n* Addiction comorbidity or schizophrenia comorbidity\n* Involuntary hospitalization\n* Seizures history\n* Pregnancy or breastfeeding\n* Somatic comorbidity able to impact on cognitive functions'}, 'identificationModule': {'nctId': 'NCT01370304', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation Compared or Associated With Venlafaxine for Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Repetitive Transcranial Magnetic Stimulation (rTMS) Compared or Associated With Venlafaxine for Depressive Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study', 'orgStudyIdInfo': {'id': '20110526-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'active rTMS and active Venlafaxine', 'interventionNames': ['Other: active rTMS and active Venlafaxine']}, {'type': 'EXPERIMENTAL', 'label': 'active rTMS and sham Venlafaxine', 'interventionNames': ['Other: active rTMS and sham Venlafaxine']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham rTMS and active Venlafaxine', 'interventionNames': ['Other: sham rTMS and active Venlafaxine']}], 'interventions': [{'name': 'active rTMS and active Venlafaxine', 'type': 'OTHER', 'otherNames': ['venlafaxine: Wyeth', 'rTMS: MagVenture'], 'description': 'rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks\n\nVenlafaxine: LP:75mg:1capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks', 'armGroupLabels': ['active rTMS and active Venlafaxine']}, {'name': 'active rTMS and sham Venlafaxine', 'type': 'OTHER', 'otherNames': ['venlafaxine: Wyeth', 'rTMS: MagVenture'], 'description': 'rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s. 5 sessions per week for 4-6 weeks', 'armGroupLabels': ['active rTMS and sham Venlafaxine']}, {'name': 'sham rTMS and active Venlafaxine', 'type': 'OTHER', 'otherNames': ['venlafaxine: Wyeth', 'rTMS: MagVenture'], 'description': 'rTMS parameters :same coil, same number of pulses but using an angled coil(90 degree)over the frontotemporal region\n\nVenlafaxine: LP:75mg:1capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks', 'armGroupLabels': ['sham rTMS and active Venlafaxine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yun chun Chen, Ph.D', 'role': 'CONTACT', 'email': 'Yunchunchen@163.com', 'phone': '+086-13720582601'}, {'name': 'Shufang Feng, Ph.D', 'role': 'CONTACT', 'email': 'fangshuan1984@yahoo.com.cn', 'phone': '+086-13227807801'}, {'name': 'Zhuo Wang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yun chun Chen', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Yunchun Chen, Ph.D', 'role': 'CONTACT', 'email': 'Yunchunchen@163.com', 'phone': '+086-13720582601'}, {'name': 'Shufang Feng, Ph.D', 'role': 'CONTACT', 'email': 'fangshuan1984@yahoo.com.cn', 'phone': '+086-13227807801'}], 'overallOfficials': [{'name': 'Qingrong Tan, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': "Department of Psychiatry, Xi Jing hospital, Xi'an, China"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fourth Military Medical University, Department of Psychosomatics, Xijing Hospital', 'investigatorFullName': 'fengshufang', 'investigatorAffiliation': 'Xijing Hospital'}}}}