Actively Recruiting

Phase Not Applicable
Age: 60Years - 85Years
All Genders
NCT07212465

Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression

Led by Rotman Research Institute at Baycrest · Updated on 2025-10-28

24

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to test whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol can reduce depressive symptoms in older adults (ages 60-85) with Major Depressive Disorder (MDD) who have not tolerated or responded to antidepressant medications. The study will evaluate whether accelerated dTMS administered over 5 consecutive days is safe and well-tolerated in this population, and whether it produces greater reductions in depressive symptoms compared to placebo stimulation.

CONDITIONS

Official Title

Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression

Who Can Participate

Age: 60Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Are between 60 and 85 years old on the day of randomization
  • Diagnosed with DSM5 Major Depressive Disorder with the current episode lasting longer than 4 weeks but less than 5 years
  • Have not responded to, not tolerated, or failed to achieve remission with at least one antidepressant trial of 8 weeks or longer
  • Willing to provide informed consent
  • Able to follow the treatment schedule
  • Stable on medications for at least 2 months and not expected to change medication during the study
  • Have passed a satisfactory safety screening questionnaire for TMS
Not Eligible

You will not qualify if you...

  • Have a metal plate or implant in the head such as ear implants, implanted brain stimulators, or aneurysm clips (non-magnetic dental devices are allowed)
  • Have known or history of increased brain pressure that may increase seizure risk
  • Have a cardiac pacemaker
  • Have an implanted medication pump
  • Have a central venous line
  • Have a history of 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 or family history of epilepsy
  • Are pregnant or breastfeeding
  • Have a history of abnormal brain MRI
  • Have untreated hypo- or hyper-thyroidism
  • Have unstable medical conditions
  • Have other known contraindications to TMS
  • Are on unstable doses of psychotropic medications such as antidepressants, antipsychotics, mood stabilizers, or memory enhancers
  • Require daily benzodiazepines or hypnotics within 2 weeks of randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rotman Research Institute at Baycrest

Toronto, Ontario, Canada, M6A 2E1

Actively Recruiting

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Research Team

A

Amanda Chao, MPH

CONTACT

L

Linda Mah, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression | DecenTrialz