NCT07212465 Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression
| NCT ID | NCT07212465 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rotman Research Institute at Baycrest |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-07-21 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-07-21 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Linda Mah, MD
PRINCIPAL INVESTIGATOR
Baycrest Rotman Research Institute
Frequently Asked Questions
Who can join the NCT07212465 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07212465 currently recruiting?
Yes, NCT07212465 is actively recruiting participants. Contact the research team at preventad@research.baycrest.org for enrollment information.
Where is the NCT07212465 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07212465 clinical trial?
NCT07212465 is sponsored by Rotman Research Institute at Baycrest. The principal investigator is Linda Mah, MD at Baycrest Rotman Research Institute. The trial plans to enroll 24 participants.