Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-03 @ 8:15 AM
Study NCT ID:
NCT02016456
Status:
COMPLETED
Last Update Posted:
2017-09-01
First Post:
2013-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TMS Treatment for Depression in the National Health Service
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2013-12-15', 'studyFirstSubmitQcDate': '2013-12-15', 'lastUpdatePostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in processing speed (using modified digit-symbol test) scores', 'timeFrame': '4 weeks and 3 months'}, {'measure': 'Change in Clinical Global Impression scores', 'timeFrame': '4 weeks and 3 months'}, {'measure': 'Change in Social and Occupational Functioning Assessment scores', 'timeFrame': '4 weeks and 3 months'}], 'primaryOutcomes': [{'measure': 'Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Mean change in Beck Depression Inventory scores', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transcranial Magnetic Stimulation', 'Neuronavigation', 'Magnetic Resonance Imaging'], 'conditions': ['Depression']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nlm.nih.gov/medlineplus/depression.html', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This research programme purports to test the effectiveness of two Transcranial Magnetic Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI) scans to improve the localization of TMS targets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of depressive disorder (DSM-IV)\n* Diagnosis of treatment resistance (at least stage 1 as defined by Thase \\& Rush, 1997 for depression)\n* Female or male between 18 and 70 years\n\nExclusion Criteria:\n\n* History of Bipolar disorder\n* Clinically relevant neurological comorbidity such as brain neoplasm, cerebral vascular events, epilepsy, neurodegenerative disorders, prior brain surgery\n* Metal objects in and around body that cannot be removed\n* Pregnancy\n* Cardiac pacemaker or implanted medication pump\n* Major unstable medical illness\n* Change in prescribed medication in the 2 weeks preceding the start of TMS trial\n* Current alcohol/stimulant dependence with propensity for toxic/withdrawal seizures'}, 'identificationModule': {'nctId': 'NCT02016456', 'acronym': 'TDEP', 'briefTitle': 'TMS Treatment for Depression in the National Health Service', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Mental Health Nottingham'}, 'officialTitle': 'An Evaluation of Transcranial Magnetic Stimulation in the National Health Service', 'orgStudyIdInfo': {'id': 'AMH/021213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Theta-Burst Stimulation', 'description': 'Theta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging)', 'interventionNames': ['Device: Theta-Burst Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Frequency stimulation', 'description': 'High frequency Transcranial Magnetic Stimulation using the standard protocol for depression, on left dorsolateral prefrontal cortex.', 'interventionNames': ['Device: High frequency stimulation']}], 'interventions': [{'name': 'Theta-Burst Stimulation', 'type': 'DEVICE', 'description': 'At 80% motor threshold determined using single pulse stimuli. Depending on the hemisphere determined by connectivity analysis and neuronavigation in each individual, either continuous (left prefrontal) or intermittent (right prefrontal) train of pulses will be delivered.', 'armGroupLabels': ['Theta-Burst Stimulation']}, {'name': 'High frequency stimulation', 'type': 'DEVICE', 'description': 'Left prefrontal stimulation. 120% motor threshold with a pulse sequence of 10 Hz for 4 seconds, followed by a 26 second quiet period. Treatment will last for a total of 37.5 minutes this is a total of 3,000 pulses', 'armGroupLabels': ['High Frequency stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG2 7UH', 'city': 'Nottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Sudheer Lankappa, MRCPsych', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nottinghamshire Healthcare NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Mental Health Nottingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nottinghamshire Healthcare NHS Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Psychiatrist', 'investigatorFullName': 'Sudheer Lankappa', 'investigatorAffiliation': 'Institute of Mental Health Nottingham'}}}}