Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression
- Conditions
- Depressive Disorder, Treatment-Resistant
- Interventions
- Device: active accelerated bilateral sequential theta burst stimulation and sham treatment
- Registration Number
- NCT06323486
- Lead Sponsor
- Ontario Shores Centre for Mental Health Sciences
- Brief Summary
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.
- Detailed Description
The CogniTReaD study is a two-arm, sham-controlled, double-blinded, treatment-sequenced, randomized clinical trial that will evaluate and explore the effects and safety of accelerated bilateral sequential theta burst stimulation (absTBS) compared to sham control in terms of improving dual-task cost, cognitive functions, depression, other outcomes (anxiety, health-related quality of life, activities of daily living, global impression, and other gait performance), and occurrence of adverse events (AE) measured at Week 2 (i.e., posttreatment acute effects) in older adults with treatment-resistant depression (TRD). We shall also evaluate the effects and safety of absTBS on improving dual-task cost, cognitive functions, depression and occurrence of AE in terms of AE occurrences measured at Week 6, Week 8, and Week 10 (i.e., posttreatment delayed effects) in older adults with TRD.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description absTBS-sham treatment sequence arm active accelerated bilateral sequential theta burst stimulation and sham treatment Those assigned to the accelerated bilateral sequential theta burst stimulation (absTBS)-sham arm shall receive the blinded active absTBS treatment at Week 1. At Week 3, they shall receive the blinded sham treatment. Sham-absTBS treatment sequence arm active accelerated bilateral sequential theta burst stimulation and sham treatment In the sham-absTBS arm, the blinded sham treatment shall be administered at Week 1. The blinded active absTBS treatment shall be given at Week 3.
- Primary Outcome Measures
Name Time Method Change in Dual-task Cost Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10 Change in Hamilton Depression Rating Scale 17 (HAMD-17) score Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10 Adverse events (AE) Week 1, Week 2, Week 3, Week 6, Week 8, and Week 10 An AE is defined as any untoward medical occurrence associated with any of the study interventions (active absTBS or sham) whether or not considered related to the study intervention.
A serious AE to any serious and unforeseen occurrence related or possibly related to the participation in the study that can lead to hospitalization, disability, or death.
- Secondary Outcome Measures
Name Time Method Change in Category Verbal Fluency (CVF) score Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10 Change in Colour Word Interference Test (CWIT) score Week 0 (baseline), Week 2 Change in Geriatric Depression Scale 30 (GDS-30) score Week 0 (baseline), Week 2 Change in Patient Health Questionnaire-9 (PHQ-9) score Week 0 (baseline), Week 2 Change in Lawton-Brody Instrumental Activities of Daily Living (LB-IADL) score Week 0 (baseline), Week 2 Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) plus modalities score Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10 Change in Digit Symbol Substitution Test (DSST) score Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10 Change in Generalized Anxiety Disorder 7 (GAD-7) score Week 0 (baseline), Week 2 Change in Alzheimer Disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL) score Week 0 (baseline), Week 2 Change in Clinical Global Impression (CGI) score Week 0 (baseline), Week 2 Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) score Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10 Change in Trail Making A (TMT-A) score Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10 Change in Trail Making B (TMT-B) score Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10 Change in Digit Span Forward (DSF) score Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10 Change in Digit Span Backward (DSB) score Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10 Change in Montreal Cognitive Assessment (MoCA) score Week 0 (baseline), Week 2 Change in Short Form 36 (SF-36) score Week 0 (baseline), Week 2 Change in Short Physical Performance Battery (SPPB) score Week 0 (baseline), Week 2 Change in Timed Up & Go (TUG) score Week 0 (baseline), Week 2
Trial Locations
- Locations (1)
Ontario Shores Centre for Mental Health Sciences
🇨🇦Toronto, Ontario, Canada