Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression

Sponsor
Centre for Addiction and Mental Health
Study ID
NCT06854367
Status
Recruiting
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Conditions

  • Depression - Major Depressive Disorder
  • Depressive Disorder, Treatment-Resistant
  • Late Life Depression (LLD)
  • Mood Disorders

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Mar 3, 2025
Start date
Mar 27, 2025
Status verified
Feb 2025
Primary completion
Nov 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Accelerated TBS
    Multiple treatments a day (5 treatments/day) for 4 consecutive days in the first week and 2 non-consecutive days in the second week.
  • Active Comparator: Conventional TBS
    Treatment once a day for 30 days (e.g., 5 days a week for 6 weeks)

Primary Outcome Measure

Depression severity [ Time Frame: 6 weeks ]

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