Accelerated deep TMS targeting the anterior cingulate for depression in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-site, double-blind, randomized, sham-controlled trial using an accelerated intermittent theta burst protocol (a-iTBS) delivered with the Brainsway H7 deep TMS coil to target the anterior cingulate cortex. Twenty-four older adults (ages 60–85) with treatment-resistant major depressive disorder will receive multiple daily dTMS sessions over five consecutive days, with either active or sham stimulation. The primary aim is to establish feasibility and tolerability of the accelerated schedule in this age group and to collect preliminary efficacy data on depressive symptom reduction. Outcomes will compare symptom change between active and sham groups and monitor safety measures such as adverse events and tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* are between 60- 85 years old (on the day of randomization)
* have been diagnosed with DSM5 Major Depressive Disorder, with the current episode longer than 4 weeks but less than 5 years
* did not respond to/did not tolerate, or failed to achieve remission with at least one antidepressant trial of 8 week minimum duration
* are willing to provide informed consent
* are able to follow the treatment schedule
* are stable on medications for 2 months and are not expected to change medication during the entire study period (if they are taking medications)
* have a satisfactory safety screening questionnaire for TMS

Exclusion Criteria:

* have a metal plate in your head (such as an ear implant, implanted brain stimulators, aneurysm clips). Dental devices and implants that are non-magnetic are safe
* have known increased pressure or a history of increased pressure in their brain, which may increase their risk for having seizures
* have a cardiac pacemaker
* have an implanted medication pump
* have a central venous line
* have a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia
* have a history of substance abuse in the last 6 months
* have a history of stroke or other brain lesions
* have a personal history of epilepsy
* have a family history of epilepsy
* are a pregnant or breast-feeding woman
* have a history of abnormal MRI of the brain
* have untreated hypo- or hyper-thyroidism
* have unstable medical condition(s)
* have any other known contraindications to TMS
* are on unstable doses of any psychotropic medication such as - antidepressants, antipsychotic, mood stabilizers or memory enhancing medications
* require daily doses of benzodiazepines or hypnotics within two weeks of randomization

Where it's running

• Rotman Research Institute at Baycrest
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Linda Mah, MD — Baycrest Rotman Research Institute
• Study coordinator: Amanda Chao, MPH
• Email: preventad@research.baycrest.org
• Phone: 416-785-2500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.