Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2026-01-25 @ 4:15 AM
Study NCT ID:
NCT01983904
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2013-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DBS for Treatment Resistant Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2013-11-07', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hamilton Depression Rating Scale', 'timeFrame': '6 and 12 months post-operatively', 'description': 'change in HDRS from baseline before surgery: rates of remission (defined as an HDRS score \\<8 at 6 and 12 months) and response (defined as \\>50% reduction in HDRS)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline on Illness Density Index, Montgomery-Asberg Depression Rating Scale and Hamilton Anxiety Scale, Positive and Negative Affect Scale, Clinical Global Impression of Change, GAF< SAs, NAS, Q-LES-Q-SF & neuropsychological tests', 'timeFrame': '6 and 12 months post operatively', 'description': 'change in MADRS score from baseline before surgery to 6 and 12 months post operatively'}, {'measure': 'Post Cognitive Behavioural Therapy Scores', 'timeFrame': '15 months post operatively', 'description': 'Changes in primary and secondary measures from pre-CBT scores will be used'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Major depressive disorder (MDD)', 'Bi-polar disorder (BP)'], 'conditions': ['Depressive Disorder, Treatment-Resistant']}, 'referencesModule': {'references': [{'pmid': '38185882', 'type': 'DERIVED', 'citation': 'Ramasubbu R, Brown EC, Mouches P, Moore JA, Clark DL, Molnar CP, Kiss ZHT, Forkert ND. Multimodal imaging measures in the prediction of clinical response to deep brain stimulation for refractory depression: A machine learning approach. World J Biol Psychiatry. 2024 Mar;25(3):175-187. doi: 10.1080/15622975.2023.2300795. Epub 2024 Jan 17.'}, {'pmid': '31860455', 'type': 'DERIVED', 'citation': 'Ramasubbu R, Clark DL, Golding S, Dobson KS, Mackie A, Haffenden A, Kiss ZH. Long versus short pulse width subcallosal cingulate stimulation for treatment-resistant depression: a randomised, double-blind, crossover trial. Lancet Psychiatry. 2020 Jan;7(1):29-40. doi: 10.1016/S2215-0366(19)30415-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects of sub-callosal cingulate (SCC) deep brain stimulation (DBS) in patients with treatment resistant depression (TRD).\n\nThe working hypotheses are that long pulse-width DBS applied to the SCC region will lead to improvements in TRD patients, and specific neuroimaging biomarkers will correlate with response to DBS; the functional recovery will be enhanced with concurrent cognitive behavioural therapy (CBT).', 'detailedDescription': 'The aim is to collect data on prediction, optimization and augmentation of DBS for TRD and develop tools for DBS surgery. It is a biological pilot study designed to provide informative data for future work.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20-70\n* diagnosis of major depressive (MDD)or bipolar disorder(BP)determined independently by 2 study psychiatrists\n* current major depressive episode of \\>1 year duration, treatment-resistant (meaning failure to respond to 4 different classes of antidepressants, including augmentation or combination strategies with lithium, atypical antipsychotics, anticonvulsants, antidepressants, evidence-based psychotherapy, CBT, or electroconvulsive treatment despite adequate dosage, duration and compliance)\n* minimum score of 20 (out of 52) on the 17 item Hamilton Depression Rating Scale (HDRS)\n* resident of Alberta, Canada, covered by Alberta Health\n\nExclusion Criteria:\n\n* other Axis I psychiatric disorders including schizophrenia, psychosis, active suicidal ideation over previous 6 months\n* cerebrovascular risk factors, previous stroke, head injury and neurodegenerative disorders, pregnancy, medical and general contraindications for DBS surgery (e.g. cardiac pacemaker/defibrillator)\n* age \\>70\n* diabetes'}, 'identificationModule': {'nctId': 'NCT01983904', 'acronym': 'CRIO-DBS', 'briefTitle': 'DBS for Treatment Resistant Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Therapeutic Brain Stimulation for Refractory Depression', 'orgStudyIdInfo': {'id': 'E-20948'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long Pulse Width', 'description': 'deep brain stimulation with short \\& long pulse width', 'interventionNames': ['Device: deep brain stimulation with short & long pulse width']}, {'type': 'EXPERIMENTAL', 'label': 'Short Pulse Width', 'description': 'deep brain stimulation with short \\& long pulse width', 'interventionNames': ['Device: deep brain stimulation with short & long pulse width']}], 'interventions': [{'name': 'deep brain stimulation with short & long pulse width', 'type': 'DEVICE', 'description': 'surgical implantation for bilateral electrodes and stimulation using short and long pulse width', 'armGroupLabels': ['Long Pulse Width', 'Short Pulse Width']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary & Alberta Health Services, Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Zelma H Kiss, MD PhDFRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary, Department of Clinical Neurosciences'}, {'name': 'Rajamannar Ramasubbu, MD MRCP FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary, Department of Psychiatry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Neurosurgery; Director Clinician Investigator Program', 'investigatorFullName': 'Zelma Kiss', 'investigatorAffiliation': 'University of Calgary'}}}}