protocolSection identificationModule nctId: NCT06323486, orgStudyIdInfo id: 23-015-B, briefTitle: Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression, acronym: CogniTReaD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Ontario Shores Centre for Mental Health Sciences, class: OTHER, collaborators name: Sunnybrook Health Sciences Centre, descriptionModule briefSummary: The CogniTReaD study is a pilot clinical trial that will compare the effects of active accelerated bilateral sequential theta burst stimulation (absTBS) and sham or inactive treatment. The goal is to see if absTBS can help older adults with treatment-resistant depression (TRD) by looking at dual-task cost and mood, as well as other cognitive functions, anxiety levels, quality of life, and physical performance, while also checking for any treatment side effects. The study will recruit participants who will receive different study treatments in a specific order. The study will be double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. The study will include people who are 50 years old or older and diagnosed with treatment-resistant depression with at least a moderate severity of depression. This study seeks to discover if absTBS can modify a dementia risk marker (i.e., dual-task cost and depression) in older patients with TRD, and to determine the effect size for larger investigations in the future., conditionsModule conditions: Depressive Disorder, Treatment-Resistant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: We will enroll patients who are willing to be randomized to either the accelerated bilateral sequential theta burst stimulation (absTBS)-sham or sham-absTBS treatment sequence arms. In the absTBS-sham sequence, participants shall receive the active absTBS treatment at Week 1, followed by sham treatment at Week 3, while in the sham-absTBS sequence, participants shall receive sham treatment at Week 1, followed by the active absTBS treatment at Week 3. The primary rationale for employing this sequential treatment strategy for both arms in this trial is to ensure that those assigned to the sham-absTBS group do not have to wait for longer periods to begin receiving the active absTBS therapy and to maintain blinding continuity., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: We shall perform a double-blinding system where the participants, study investigators, transcranial magnetic stimulation (TMS) technicians (those who operate and administer TMS procedures), and research assistants (outcome assessors) are masked to the assignment of the enrolled participants., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: active accelerated bilateral sequential theta burst stimulation and sham treatment, outcomesModule primaryOutcomes measure: Change in Dual-task Cost, primaryOutcomes measure: Change in Hamilton Depression Rating Scale 17 (HAMD-17) score, primaryOutcomes measure: Adverse events (AE), secondaryOutcomes measure: Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) score, secondaryOutcomes measure: Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) plus modalities score, secondaryOutcomes measure: Change in Trail Making A (TMT-A) score, secondaryOutcomes measure: Change in Trail Making B (TMT-B) score, secondaryOutcomes measure: Change in Digit Symbol Substitution Test (DSST) score, secondaryOutcomes measure: Change in Digit Span Forward (DSF) score, secondaryOutcomes measure: Change in Digit Span Backward (DSB) score, secondaryOutcomes measure: Change in Category Verbal Fluency (CVF) score, secondaryOutcomes measure: Change in Montreal Cognitive Assessment (MoCA) score, secondaryOutcomes measure: Change in Colour Word Interference Test (CWIT) score, secondaryOutcomes measure: Change in Patient Health Questionnaire-9 (PHQ-9) score, secondaryOutcomes measure: Change in Geriatric Depression Scale 30 (GDS-30) score, secondaryOutcomes measure: Change in Generalized Anxiety Disorder 7 (GAD-7) score, secondaryOutcomes measure: Change in Short Form 36 (SF-36) score, secondaryOutcomes measure: Change in Alzheimer Disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL) score, secondaryOutcomes measure: Change in Lawton-Brody Instrumental Activities of Daily Living (LB-IADL) score, secondaryOutcomes measure: Change in Clinical Global Impression (CGI) score, secondaryOutcomes measure: Change in Short Physical Performance Battery (SPPB) score, secondaryOutcomes measure: Change in Timed Up & Go (TUG) score, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ontario Shores Centre for Mental Health Sciences, status: RECRUITING, city: Toronto, state: Ontario, zip: L1N 5S9, country: Canada, contacts name: Amer M. Burhan, MBChB, MSc, role: CONTACT, phone: 905.430.4055, phoneExt: 4019, email: burhana@ontarioshores.ca, contacts name: Adrian I. Espiritu, MD, role: CONTACT, phone: 905.430.4055, phoneExt: 6271, email: espiritua@ontarioshores.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False