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

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 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

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.

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