Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-02 @ 12:08 PM
Study NCT ID:
NCT06746857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2024-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iTBS-Neurosplasticity for Female Youth With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2024-12-18', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Rating Scale Depression', 'timeFrame': 'Four weeks', 'description': 'Minimum score: 0; Maximum score: 52; higher scores mean worse outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'TBC', 'detailedDescription': 'TBs'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. are assigned female sex at birth;\n2. are 16yo to 24yo;\n3. outpatients;\n4. are competent to assent (those age 16-18) or consent to participate (those age 19-24);\n5. have a Diagnostic and Statistical Manual of Mental Disorders Fifth edition (DSM 5) diagnosis of Major Depressive Episode by Mini-International Neuropsychiatric Interview (MINI) version 7.0.0 for participants aged 18-24 and Adolescents (MINI-KID) for participants aged 16-17;\n6. have a score ≥ 18 on the Hamilton Depression Rating Scale (HDRS-17 item) or Depressive symptom severity as shown by a total Children's Depression Rating Scale Revised (CDRS-R) score 40;\n7. have not changed dose or initiated a new regular antidepressant or antidepressant augmentation treatment(s) for 4 weeks prior to starting TMS treatment;\n8. are able to adhere to the treatment schedule;\n9. pass both the TMS and MRI adult safety screening questionnaires.\n\nExclusion Criteria:\n\n1. have Moderate or Severe Substance Use Disorder (except tobacco) within the last three (3) months;\n2. have a concomitant major unstable medical illness;\n3. have active suicidal intent;\n4. have not responded to 2 or more adequate trials of antidepressant medication in the current episode as meassured by the ATHF form\n5. are pregnant or planning to become pregnant during the study period;\n6. have a lifetime (MINI) diagnosis of any psychotic disorder;\n7. have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDE;\n8. have previously had ECT or rTMS;\n9. have any significant neurological disorder or any significant head trauma with clear radiological evidence of cerebrovascular injury on imaging.\n10. have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;\n11. have history of epilepsy\n12. are participating in standardized regular psychotherapy provided by a psychiatrist or a registered psychologist for less than 3 months prior to study entry or planning to start during the course of rTMS treatments;\n13. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;\n14. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview);"}, 'identificationModule': {'nctId': 'NCT06746857', 'briefTitle': 'iTBS-Neurosplasticity for Female Youth With Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'iTBS-Neurosplasticity for Female Youth With Depression', 'orgStudyIdInfo': {'id': 'H22-02593'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Accelerated iTBS', 'interventionNames': ['Device: repetitive transcranial magnetic stimulation']}], 'interventions': [{'name': 'repetitive transcranial magnetic stimulation', 'type': 'DEVICE', 'description': 'Bilateral dorsolateral prefrontal cortex Intermitten Theta Burst Stimulation to', 'armGroupLabels': ['Accelerated iTBS']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alice Erchov', 'role': 'CONTACT', 'email': 'ninet.lab@ubc.ca', 'phone': '604-822-1361'}], 'overallOfficials': [{'name': 'Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA', 'investigatorAffiliation': 'University of British Columbia'}}}}