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Behavioural Intervention

Theta-Burst Stimulation for Bipolar Disorder (TRIBE Trial)

N/A
Recruiting
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to 6 weeks post-treatment
Awards & highlights

Summary

This trial aims to see if a certain type of brain stimulation can help reduce depression symptoms in people with bipolar disorder. Participants will either receive the active stimulation or a fake stimulation for 30 days, and

Who is the study for?
This trial is for individuals with bipolar disorder who have not responded well to standard treatments for depression. Participants must be able to attend 30 treatment sessions and follow-up visits. Specific criteria will determine eligibility.
What is being tested?
The study tests if iTBS, a brain stimulation technique, can alleviate depression in those with treatment-resistant bipolar disorder. Half receive real iTBS; the other half get sham (fake) treatment, decided randomly.
What are the potential side effects?
Possible side effects of iTBS may include discomfort at the stimulation site, headache, lightheadedness, or seizures. Sham treatment has no active side effects but may cause placebo effect symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to 6 weeks post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 6 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
Secondary study objectives
Symptoms of Mania

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active iTBS StimulationExperimental Treatment1 Intervention
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.
Group II: Sham iTBS StimulationPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoOTHER
1,514 Previous Clinical Trials
500,081 Total Patients Enrolled
16 Trials studying Bipolar Disorder
1,272 Patients Enrolled for Bipolar Disorder
Centre for Addiction and Mental HealthLead Sponsor
366 Previous Clinical Trials
82,212 Total Patients Enrolled
15 Trials studying Bipolar Disorder
1,395 Patients Enrolled for Bipolar Disorder
~83 spots leftby May 2029
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