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Behavioural Intervention
Active iTBS Stimulation for Depression, Bipolar Disorder (TRIBE Trial)
N/A
Waitlist Available
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
TRIBE Trial 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.Check my 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.See study design
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.
TRIBE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to 6 weeks post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to 6 weeks post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
Secondary outcome measures
Symptoms of Mania
TRIBE 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
1,476 Previous Clinical Trials
485,056 Total Patients Enrolled
Centre for Addiction and Mental HealthLead Sponsor
356 Previous Clinical Trials
81,334 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which individuals meet the eligibility criteria to participate in this clinical study?
"To qualify for participation, individuals must have a diagnosis of depression or bipolar disorder and fall between the ages of 18 to 65. The study aims to recruit 124 eligible candidates in total."
Answered by AI
Is the clinical trial open to individuals who are younger than 60 years old?
"To be eligible for this research endeavor, potential candidates must fall within the age bracket of 18 to 65 years. Notably, there are a total of 254 trials tailored specifically for individuals under 18 and another 1116 trials designated for those above the age of 65."
Answered by AI
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