nctId: NCT06323486 id: 23-015-B briefTitle: Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression acronym: CogniTReaD overallStatus: RECRUITING date: 2024-04-01 date: 2026-03-30 date: 2026-03-30 date: 2024-03-21 date: 2024-03-21 name: Ontario Shores Centre for Mental Health Sciences class: OTHER name: Sunnybrook Health Sciences Centre 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. conditions: Depressive Disorder, Treatment-Resistant studyType: INTERVENTIONAL phases: NA 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 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 count: 54 type: ESTIMATED name: active accelerated bilateral sequential theta burst stimulation and sham treatment measure: Change in Dual-task Cost measure: Change in Hamilton Depression Rating Scale 17 (HAMD-17) score measure: Adverse events (AE) measure: Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) score measure: Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) plus modalities score measure: Change in Trail Making A (TMT-A) score measure: Change in Trail Making B (TMT-B) score measure: Change in Digit Symbol Substitution Test (DSST) score measure: Change in Digit Span Forward (DSF) score measure: Change in Digit Span Backward (DSB) score measure: Change in Category Verbal Fluency (CVF) score measure: Change in Montreal Cognitive Assessment (MoCA) score measure: Change in Colour Word Interference Test (CWIT) score measure: Change in Patient Health Questionnaire-9 (PHQ-9) score measure: Change in Geriatric Depression Scale 30 (GDS-30) score measure: Change in Generalized Anxiety Disorder 7 (GAD-7) score measure: Change in Short Form 36 (SF-36) score measure: Change in Alzheimer Disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL) score measure: Change in Lawton-Brody Instrumental Activities of Daily Living (LB-IADL) score measure: Change in Clinical Global Impression (CGI) score measure: Change in Short Physical Performance Battery (SPPB) score measure: Change in Timed Up & Go (TUG) score sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ontario Shores Centre for Mental Health Sciences status: RECRUITING city: Toronto state: Ontario zip: L1N 5S9 country: Canada name: Amer M. Burhan, MBChB, MSc role: CONTACT phone: 905.430.4055 phoneExt: 4019 email: burhana@ontarioshores.ca name: Adrian I. Espiritu, MD role: CONTACT phone: 905.430.4055 phoneExt: 6271 email: espiritua@ontarioshores.ca lat: 43.70011 lon: -79.4163 hasResults: False