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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
280
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.
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGCentre for Addiction and Mental Healh
Toronto, Ontario, Canada
RECRUITINGDepression severity
Montgomery Asberg Depression Rating Scale (MADRS) Change
Time frame: 6 weeks
Depression severity
17 item Hamilton Depression Rating Scale (HDRS-17) Change
Time frame: up to 10 weeks
Depression severity
The Beck Depression Inventory (BDI-II) Change
Time frame: up to 10 weeks
Anxiety severity
General Anxiety Disorder-7 (GAD-7) Change
Time frame: up to 10 weeks
Suicidal ideation
The Beck Scale for Suicide Ideation (BSS) Change
Time frame: up to 10 weeks
Global cognition
Montreal Cognitive Assessment (MoCA) Change
Time frame: up to 10 weeks
Executive function
Delis-Kaplan Executive Function System (D-KEFS) Change
Time frame: up to 10 weeks
Executive function
NIH Toolbox Flanker Inhibitory Control and Attention Test
Time frame: up to 10 weeks
Memory
California Verbal Learning Test- third edition (CVLT-3) Change
Time frame: up to 10 weeks
Disability and Functional Impairment
Sheehan Disability Scale (SDS) Change
Time frame: up to 10 weeks
Quality of Life Measure
Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q) change
Time frame: up to 10 weeks
Quality of Life Measure
World Health Organization Quality of Life Short Version (WHOQOL-BREF) Change
Time frame: up to 10 weeks
Participant Expectancy of Improvement and Preference
Modified Stanford Expectations of Treatment Scale (SETS)
Time frame: Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.