High-Dose iTBS for Depression

Recruiting at 2 trial locations

Overseen By Elizabeth Clancy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Must not be taking: Anticonvulsants, others

Disqualifiers: Substance abuse, Bipolar, Schizophrenia, OCD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 81

Duration: 1 week

228 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will compare active intermittent theta burst stimulation (iTBS) rTMS in an accelerated treatment schedule (8 treatment sessions per day for 5 days) to a placebo control. Depression symptom severity will be measured before, during, at end of treatment, 1-week post and 4-weeks post treatment.

Research Team

Daniel Blumberger, MD

Principal Investigator

CAMH

Eligibility Criteria

This trial is for outpatients aged 18-65 with major depressive disorder, who haven't responded well to antidepressants or can't tolerate them. Participants must have a certain depression score, be able to follow the treatment schedule, and not be on new psychotropic meds for the last 4 weeks. Exclusions include unstable medical conditions, metal implants near the head, pregnancy, certain psychiatric diagnoses like bipolar or schizophrenia, substance abuse within 3 months, high risk of suicide or taking specific medications.

Inclusion Criteria

I am between 18 and 65 years old.

I haven't started or increased any mental health medication in the last 4 weeks.

have a score > 18 on the HRSD-17 item

Exclusion Criteria

I have had ECT treatment before that did not work for me.

have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed

I do not have major brain or nerve conditions like severe head injury, Parkinson's, or multiple sclerosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active or sham iTBS administered 8 times daily for 5 days

1 week

40 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Assessments at 1-week and 4-weeks post-treatment

Open-label extension

Participants not meeting response criteria at 4-week follow-up are offered a second course of active rTMS treatment

1 week

40 sessions (in-person)

Treatment Details

Interventions

• Active iTBS
• Sham iTBS

Trial Overview The study tests an accelerated schedule of active intermittent theta burst stimulation (iTBS) against a placebo control over five days. iTBS is a type of repetitive transcranial magnetic stimulation (rTMS), which uses magnetic fields to stimulate nerve cells in the brain. Depression severity will be measured at multiple points before and after treatment.

Participant Groups

Group I: Active iTBS Experimental Treatment 1 Intervention

Administered 8 times daily at approximately 50 minutes intervals (between session end and start) for 5 days. Each session will deliver 1800 pulses of active iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / \~10 minutes) at a target intensity of 110% of the subject's resting motor threshold.

Group II: Sham iTBS Placebo Group 1 Intervention

Administered 8 times daily at approximately 50 minutes intervals (between session end and start) for 5 days, using a sham coil that reproduces auditory and tactile sensations of stimulation and has an identical external appearance. Each session will deliver 1800 pulses of sham iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / \~10 minutes) at a target intensity of 110% of the subject's resting motor threshold.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+