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| Name | Class |
|---|---|
| Sunnybrook Health Sciences Centre | OTHER |
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The purpose of this trial is to compare the treatment efficacy (improvement in depressive symptoms) of accelerated TBS protocol (where participants receive multiple TBS treatments daily) to conventional TBS protocol (where participants receive a single TBS treatment daily) in late life depression. In addition, the study also aims to determine if specific patterns of stimulation are more or less effective. To do this, all participants will receive active treatments, but some of the participants in this study will receive accelerated TBS and some will receive once daily TBS.
The purpose of this trial is to compare the treatment efficacy (change in MADRS scores) of accelerated TBS to conventional TBS in participants with moderate to severe LLD at 4-weeks following accelerated TBS or following 30 once daily treatments of conventional TBS. Accelerated TBS group will receive 5 treatment sessions per day at approximately 1 hour intervals for 4 consecutive days on week 1 and 2 non-consecutive days on week 2. Conventional TBS group will receive 30 once daily treatment (approximately 6 weeks). Each treatment will consist of either 1) cTBS of right DLPFC followed by iTBS of left DLPFC; or 2) iTBS of left DLPFC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerated TBS | Active Comparator | Multiple treatments a day (5 treatments/day) for 4 consecutive days in the first week and 2 non-consecutive days in the second week. |
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| Conventional TBS | Active Comparator | Treatment once a day for 30 days (e.g., 5 days a week for 6 weeks) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBS | Device | Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive neurostimulation that uses focused magnetic field pulses to directly stimulate cortical neurons. Theta burst stimulation (TBS) is a briefer form of patterned rTMS that has been shown to be effective against major depressive disorder. Each treatment will consist of either 1) cTBS of right DLPFC followed by iTBS of left DLPFC; or 2) iTBS of left DLPFC. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression severity | Montgomery Asberg Depression Rating Scale (MADRS) Change | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depression severity | 17 item Hamilton Depression Rating Scale (HDRS-17) Change | up to 10 weeks |
| Depression severity | The Beck Depression Inventory (BDI-II) Change |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001523 | Mental Disorders |
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|
| up to 10 weeks |
| Anxiety severity | General Anxiety Disorder-7 (GAD-7) Change | up to 10 weeks |
| Suicidal ideation | The Beck Scale for Suicide Ideation (BSS) Change | up to 10 weeks |
| Global cognition | Montreal Cognitive Assessment (MoCA) Change | up to 10 weeks |
| Executive function | Delis-Kaplan Executive Function System (D-KEFS) Change | up to 10 weeks |
| Executive function | NIH Toolbox Flanker Inhibitory Control and Attention Test | up to 10 weeks |
| Memory | California Verbal Learning Test- third edition (CVLT-3) Change | up to 10 weeks |
| Disability and Functional Impairment | Sheehan Disability Scale (SDS) Change | up to 10 weeks |
| Quality of Life Measure | Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q) change | up to 10 weeks |
| Quality of Life Measure | World Health Organization Quality of Life Short Version (WHOQOL-BREF) Change | up to 10 weeks |
| Participant Expectancy of Improvement and Preference | Modified Stanford Expectations of Treatment Scale (SETS) | Baseline |
| Centre for Addiction and Mental Healh | Recruiting | Toronto | Ontario | M6J 1H1 | Canada |
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