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Behavioural Intervention

High-Dose iTBS for Depression

N/A

Recruiting

Led By Daniel Blumberger, MD

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

are between the ages of 18 and 65

have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score for that antidepressant trial of > 3 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF score of 1 or 2 on those 2 separate antidepressants)

Must not have

have failed a course of ECT in the current episode or previous episode

have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than 5 minutes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 5 treatment days and at 1-week and 4 weeks post-treatment

Summary

This trial will compare a brain stimulation treatment to a placebo control to see if the brain stimulation treatment can help people with depression.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While side effects are not explicitly listed here, rTMS treatments like iTBS may cause headaches or scalp discomfort at the site of stimulation; rare risks include seizures and hearing loss if ear protection isn't used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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My depression hasn't improved after trying at least one strong antidepressant or I couldn't tolerate 2 different ones.

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I am not currently hospitalized.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I do not have a serious unstable illness, pacemaker, or implanted medication pump.

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I take no more than 2 mg of lorazepam daily or any anticonvulsant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 5 treatment days and at 1-week and 4 weeks post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 5 treatment days and at 1-week and 4 weeks post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 5 treatment days and at 1-week and 4 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)

Change on the Beck Depression Inventory-II (BDI-II)

Change on the Generalized Anxiety Disorder 7-Item (GAD-7)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active iTBSExperimental Treatment1 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 iTBSPlacebo Group1 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.

0 / 7Eligibility criteria met