228 Participants Needed

High-Dose iTBS for Depression

Recruiting at 2 trial locations
SS
MS
EC
Overseen ByElizabeth Clancy
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre for Addiction and Mental Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Daniel Blumberger | Department of ...

Daniel Blumberger, MD

Principal Investigator

CAMH

Are You a Good Fit for This Trial?

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 haven't started or increased any mental health medication in the last 4 weeks.
have a score > 18 on the HRSD-17 item
able to adhere to the treatment schedule
See 6 more

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.
See 12 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active iTBSExperimental Treatment1 Intervention
Group II: Sham iTBSPlacebo Group1 Intervention

Find a Clinic Near You

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+
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