Recruiting NA Major Depressive Disorder

New treatment option for Major Depressive Disorder

Official title Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults

ClinicalTrials.gov ID: NCT03665831

What this study is testing

What it's testing: In this study, the investigators will be examining the effects of the deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60 diagnosed with mild to early-moderate Alzheimer's disease (AD) or mild cognitive impairment (MCI) and comorbid Major Depressive Disorder (MDD) who have been unable to tolerate or failed to respond to antidepressant medications. The coil was designed to stimulate deeper regions of the left dorsolateral prefrontal cortex (DLPFC).

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

Who can take part

Ages 60 and older

You may be able to join if

meet DSM 5 criteria for Major or Mild Neurocognitive Disorder due to Alzheimer's disease with Clinical Dementia Rating Scale (CDR) score of at least...
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 or did not tolerate antidepressant treatment
are willing to provide informed consent
are able to follow the treatment schedule

You likely can't join if

have a metal plate in their head, except in the mouth (such as an ear implant, implanted brain stimulators, aneurysm clips)
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 significant heart disease or history of stroke

See the full eligibility criteria

Who can join

meet DSM 5 criteria for Major or Mild Neurocognitive Disorder due to Alzheimer's disease with Clinical Dementia Rating Scale (CDR) score of at least 0.5
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 or did not tolerate antidepressant treatment
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
have an informant/study partner who is able to complete study questionnaires regarding the participant

What rules you out

have a metal plate in their head, except in the mouth (such as an ear implant, implanted brain stimulators, aneurysm clips)
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 significant heart disease or history of stroke
Modified Hachinski Score (MHIS) \> 3 (to exclude those with significant vascular component to memory loss)
have a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia other than AD
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
are taking psychotropic medications including antidepressant medications, antipsychotics or mood stabilizing medications due to increased risk of seizure
are taking memantine
have a history of abnormal MRI of the brain
have significant hearing loss requiring use of hearing aids
have untreated hypo- or hyper-thyroidism

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 and older. 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.