Active not recruitingNAINTERVENTIONAL

Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression

This study is looking at two types of brain stimulation, called repetitive Transcranial Magnetic Stimulation (rTMS) and deep Transcranial Magnetic Stimulation (dTMS), for people with major depression that hasn't gotten better with standard treatments. Researchers want to find out which of these two methods is more effective at reducing depression symptoms. They are also looking for ways to predict who might benefit most from these treatments. Participants will be randomly assigned to receive either rTMS or dTMS. The study aims to provide clearer answers than previous research, helping to improve treatment options for those living with persistent depression.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

Start

01 Jan 2024

Estimated completion

01 Jan 2026

Major Depressive Disorder

What is this study about?

This study is a clinical trial designed to compare two similar but slightly different treatments for major depression. These treatments involve using magnetic pulses to stimulate specific areas of the brain, a technique known as Transcranial Magnetic Stimulation, or TMS. The two types being compared are repetitive TMS (rTMS) and deep TMS (dTMS).

Previous research has suggested that dTMS might be more effective than rTMS because it can reach a slightly broader area of the brain, making it easier to target the right spot. However, past studies haven't always been able to definitively prove this difference, often due to a small number of participants or not enough treatment sessions. This new study aims to overcome those limitations by carefully comparing the two methods, hoping to show if one truly works better than the other.

The main goal is to find out if dTMS is superior to rTMS in helping people with major depression whose symptoms haven't improved with at least two different antidepressant medications. Finding a more effective treatment could make a big difference for individuals living with this long-term and challenging condition, improving their chances of feeling better.

Key takeaways

This study compares two types of brain stimulation (rTMS and dTMS) for major depression.
It aims to find out if one treatment is more effective for people who haven't responded to antidepressants.
Participants will be randomly assigned to receive either rTMS or dTMS.
Eligibility is for those with moderate to severe major depression who meet specific criteria.
The study hopes to improve future treatment options for persistent depression.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you must have been diagnosed with major depression that is at least moderately severe. This means your depression hasn't gotten better after trying at least two different antidepressant medications, or you couldn't tolerate them. You should also be taking a stable antidepressant dose for at least four weeks before the study starts.

There are also some specific situations that would prevent you from taking part. For example, if you've had TMS treatment before, or have a history of bipolar disorder or psychosis, you wouldn't be able to join. Certain medical conditions, like having a pacemaker or a severe unstable illness, also mean you can't participate.

Your doctor or the study team will ask detailed questions to make sure the study is safe and suitable for you. They will check if any other conditions, like severe anxiety, are the main cause of your difficulties, as the study specifically focuses on major depression. If you're pregnant, actively suicidal, or have certain implants in your body, you also won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a diagnosis of major depression that is at least moderately severe?
Have I tried at least two different antidepressant medications without enough improvement?
Am I on a stable dose of antidepressant medication for the past four weeks?
Do I currently have any metal implants or a pacemaker in my body?
Have I had TMS treatment for depression before?
Am I pregnant or do I have active suicidal thoughts?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening process to ensure you meet all the requirements. Once confirmed, you'll be randomly assigned to one of two groups: either receiving repetitive TMS (rTMS) or deep TMS (dTMS). This random assignment means neither you nor the researchers get to choose which treatment you receive, ensuring a fair comparison.

Both rTMS and dTMS involve a series of treatment sessions where a device is placed on your head to deliver magnetic pulses. The exact number of sessions and the total duration of your participation will be explained in detail by the study team. You will likely have regular appointments and assessments throughout the study to monitor your depression symptoms and overall well-being. This might involve filling out questionnaires or having brief discussions with the study doctors. You will continue with your current antidepressant medication regimen, provided it has been steady for at least four weeks before the study begins. The study team will provide all the necessary information about appointments, what to expect during sessions, and any follow-up care. The specifics of the schedule and overall time commitment will be provided to you before you agree to participate.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a novel brain stimulation treatment for your depression that might be more effective than your current treatment. You would also be contributing to medical knowledge that could help countless others with similar conditions in the future. However, there are potential risks, like any medical procedure. TMS can sometimes cause mild side effects such as headaches, scalp discomfort, or facial twitching during treatment. Rarely, more serious side effects like seizures can occur, although steps are taken to minimise this risk. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care. All procedures and potential risks will be thoroughly explained to you before you decide to join.

Locations (1)

CHUM
Verified postcode
Montreal, Canada

Common questions

What is TMS?

TMS (Transcranial Magnetic Stimulation) is a treatment that uses magnetic pulses to stimulate specific areas of your brain to help reduce symptoms of depression.

What's the difference between rTMS and dTMS?

Both are types of TMS, but deep TMS (dTMS) delivers magnetic pulses to a slightly wider area of the brain compared to repetitive TMS (rTMS), which might make it more effective.

Will I know which treatment I'm getting?

No, you will be randomly assigned to either rTMS or dTMS, meaning you won't get to choose, and sometimes the researchers won't know either, to ensure a fair comparison.

Can I continue my antidepressant medication during the study?

Yes, you generally need to be on a stable antidepressant medication regimen that hasn't changed for at least four weeks before starting the study.

What if my depression gets worse during the study?

Your well-being is a priority. The study team will monitor you closely, and you can always discuss any concerns with them. You also have the option to withdraw from the study at any time.