Recruiting NA Major Depressive Disorder (MDD)

New treatment option for Major Depressive Disorder (MDD)

Official title Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression

ClinicalTrials.gov ID: NCT07212465

What this study is testing

What it's testing: 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.

You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 60 to 85

You may be able to join if

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

You likely can't join if

have a metal plate in your head (such as an ear implant, implanted brain stimulators, aneurysm clips). Dental devices and implants that are...
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...

See the full eligibility criteria

Who can join

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

What rules you out

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

The study team makes the final eligibility decision.

Where it's taking place

Toronto, Ontario, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 60 years to 85 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.