Theta-Burst Stimulation for Bipolar Depression

Sponsor
Centre for Addiction and Mental Health
Study ID
NCT06370988
Status
Recruiting
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Conditions

  • Bipolar Depression
  • Bipolar Disorder
  • Treatment- Resistant Bipolar Disorder
  • Type 2 Bipolar Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • iTBS Stimulation — DEVICE
    Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30
  • Sham iTBS Stimulation — DEVICE
    Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30

Study Details

The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation. Participants will come for 30 days of either active iTBS or sham iTBS, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion.

Key Dates

First listed
Apr 17, 2024
Start date
May 15, 2024
Status verified
Mar 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

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

Arms

  • Sham Comparator: Sham iTBS Stimulation
    Administered once daily over 30 days, using a sham coil that reproduces auditory and tactile sensations of stimulation and has an identical external appearance. Each session will deliver 600 pulses of sham iTBS in triplet 50Hz bursts, repeated at 5Hz 2s on 8s off for a total time of \~3 minutes, 9 seconds at a target intensity of 120% of the subject's resting motor threshold.
  • Experimental: Active iTBS Stimulation
    Administered once daily over 30 days. Each session will deliver 600 pulses of active iTBS in triplet 50Hz bursts, repeated at 5Hz 2s on 8s off for a total time of \~3 minutes, 9 seconds at a target intensity of 120% of the subject's resting motor threshold.

Primary Outcome Measure

Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17) [ Time Frame: From enrollment to 6 weeks post-treatment ]

Central Contacts

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