Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-18 @ 2:01 AM
Study NCT ID:
NCT02778035
Status:
UNKNOWN
Last Update Posted:
2018-03-14
First Post:
2016-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Different Patterns of rTMS in Major Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-13', 'studyFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2016-05-18', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '17-Item Hamilton Rating Scale for Depression (HAMD-17)', 'timeFrame': 'Baseline, after each week of treatment (i.e. after 5 days of treatment), and 1, 4, and 12 weeks post-treatment. Treatment will include 5 daily weekday visits over 4 weeks (20 sessions total).', 'description': 'Outcome measured by a change in HAMD-17 score from baseline to 1-week post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of ≤7 is categorized as remission.'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'Daily for 4 weeks, 5 days per week, in addition to three follow-up visits at 1, 4, and 12 weeks post-treatment', 'description': 'Outcome measured by a change in BDI-II score from baseline to 1-week post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of ≤12 is categorized as remission.'}]}, 'conditionsModule': {'conditions': ['Depression; Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '39448077', 'type': 'DERIVED', 'citation': 'Goodman MS, Schulze L, Daskalakis ZJ, Konstantinou GN, Mansouri F, Trevizol AP, Blumberger DM, Downar J. Randomised controlled trial comparing different intersession intervals of intermittent theta burst delivered to the dorsal medial prefrontal cortex. BMJ Ment Health. 2024 Oct 23;27(1):e301290. doi: 10.1136/bmjment-2024-301290.'}]}, 'descriptionModule': {'briefSummary': 'This trial will compare the trajectories of improvement for three different patterns of twice-daily rTMS in major depression: two daily sessions of dorsomedial prefrontal rTMS delivered at 0 min vs. 30 min vs. 60 min intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Participants are eligible for the study if they:\n\n1. are outpatients\n2. are voluntary and competent to consent to treatment\n3. have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of major depressive disorder (MDD), single or recurrent, or Bipolar Disorder with a current Major Depressive Episode\n4. are between the ages of 18 and 65\n5. have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of \\> 3 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)\n6. have a score ≥18 on the 17-item Hamilton Rating Scale for Depression (HRSD-17)\n7. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening\n8. are able to adhere to the treatment schedule\n9. pass the TMS safety-screening questionnaire\n10. have normal thyroid functioning and no clinically significant abnormalities on complete blood count (CBC), on pre-study blood work.\n\nParticipants are ineligible for the study if they:\n\n1. have a history of substance dependence or abuse within the last 3 months\n2. have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump\n3. have active suicidal intent\n4. are pregnant\n5. have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms\n6. have a MINI diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary and causing greater impairment than MDD\n7. have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD\n8. have failed a course of electroconvulsive therapy (ECT) in the current episode or previous episode\n9. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes\n10. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed\n11. if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study\n12. have a clinically significant laboratory abnormality, in the opinion of the investigator\n13. currently (or in the last 4 weeks prior to the study) have taken more than lorazepam 4 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy\n14. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)."}, 'identificationModule': {'nctId': 'NCT02778035', 'briefTitle': 'Comparing Different Patterns of rTMS in Major Depression', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Different Patterns of Repetitive Transcranial Magnetic Stimulation in the Treatment of Refractory Depression', 'orgStudyIdInfo': {'id': '15-9615'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '60 min inter-session interval', 'description': 'Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 60 min).', 'interventionNames': ['Device: Dorsomedial prefrontal rTMS']}, {'type': 'EXPERIMENTAL', 'label': '30 min inter-session interval', 'description': 'Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 30 min).', 'interventionNames': ['Device: Dorsomedial prefrontal rTMS']}, {'type': 'EXPERIMENTAL', 'label': '0 min inter-session interval', 'description': 'Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 0 min).', 'interventionNames': ['Device: Dorsomedial prefrontal rTMS']}], 'interventions': [{'name': 'Dorsomedial prefrontal rTMS', 'type': 'DEVICE', 'description': 'Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval', 'armGroupLabels': ['0 min inter-session interval', '30 min inter-session interval', '60 min inter-session interval']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Laura Schulze', 'role': 'CONTACT', 'email': 'laura.schulze@uhn.ca', 'phone': '416-603-5667'}, {'name': 'Terri Cairo', 'role': 'CONTACT', 'email': 'terri.cairo@uhn.ca', 'phone': '416-603-5667'}, {'name': 'Jonathan Downar, MD PhD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UHN MRI-Guided rTMS Clinic, Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6J 1H4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Shobha Mehta', 'role': 'CONTACT', 'email': 'shobha.mehta@camh.ca'}, {'name': 'Daniel M Blumberger, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zafiris J Daskalakis, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Laura Schulze', 'role': 'CONTACT', 'email': 'laura.schulze@uhn.ca', 'phone': '416-603-5667', 'phoneExt': '6513'}, {'name': 'Terri Cairo', 'role': 'CONTACT', 'email': 'terri.cairo@uhn.ca', 'phone': '416-603-5667', 'phoneExt': '4950'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}