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RecruitingPHASE1INTERVENTIONAL

Theta-Burst Stimulation to Treat Depression

This research is testing a gentle brain stimulation treatment called iTBS (intermittent theta-burst stimulation) for people with depression. iTBS uses magnetic pulses to change brain activity. The aim is to see if it can improve depression symptoms and how well the brain can adapt and change, known as brain plasticity. The study compares two different ways of giving iTBS: a 'spaced' method and a 'compressed' method. Participants will try both methods at different times. We want to find out which approach is better at helping the brain to recover and reducing the impact of depression. This could lead to better treatments for Major Depressive Disorder.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Centre for Addiction and Mental Health
Enrolment target
84
Start
01 Jun 2025
Estimated completion
01 Dec 2026

What is this study about?

Many people with depression find that current treatments don't fully work for them, or they have side effects. That's why researchers are always looking for new and improved ways to help. This study is focusing on a treatment called iTBS, which stands for intermittent theta-burst stimulation. It's a type of brain stimulation that uses magnetic pulses to gently encourage changes in the brain.

Think of your brain as having lots of connections, like roads. When you have depression, some of these roads might not be working as well as they should. iTBS aims to help strengthen those connections, making your brain more adaptable and able to heal. This ability of the brain to change and reorganise itself is called 'brain plasticity'. By improving this, we hope to see a reduction in depression symptoms.

In this study, we're comparing two different ways of giving the iTBS treatment: one called 'spaced' and another called 'compressed'. Participants will experience both methods to help researchers understand if one is more effective than the other at improving brain plasticity and relieving depression. Your participation will help us learn more about how to best use this promising treatment.

Key takeaways

  • This study investigates a new type of brain stimulation called iTBS for depression.
  • It compares two different ways of giving iTBS treatment.
  • The goal is to improve depression symptoms and the brain's ability to change and adapt.
  • Participation involves about 5 visits over 2-3 months, including brain scans and treatment sessions.
  • You will continue your current stable antidepressant medication.
  • Your contribution could help shape future depression treatments.

Who may be eligible?

To join this study, you need to be an adult between 18 and 50 years old and have been diagnosed with Major Depressive Disorder. If you're currently taking antidepressant medication, it needs to have been at a steady dose for at least 4 weeks before you start the study. You also need to be right-handed or able to use both hands, and understand English well enough to follow instructions.

There are some reasons why you wouldn't be able to join. These include if you are younger than 18 or older than 50, or if you have certain other mental health conditions like bipolar disorder or a history of psychosis. We also can't include people who have a high risk of suicide.

For safety reasons, you can't take part if you have any metal implants in your body (like a pacemaker or certain dental work), have a history of seizures, or are pregnant. Also, if you're taking certain medications like antipsychotics or anti-epileptic drugs, or some sedatives, you might not be eligible, as these can affect how the brain stimulation works. However, if you're taking gabapentin or pregabalin for chronic pain and your dose has been steady for 4 weeks, you might still be able to join.

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.

  1. Are you between 18 and 50 years old?
  2. Have you been diagnosed with Major Depressive Disorder?
  3. If taking antidepressants, has your dose been stable for at least 4 weeks?
  4. Are you right-handed or ambidextrous (able to use both hands)?
  5. Do you have any metal implants (like a pacemaker) or a history of seizures?
  6. Are you pregnant or think you might be?
Answer every question to see your result.

What does participation involve?

If you decide to take part, your commitment will involve about 5 study visits spread over 2 to 3 months. This is what you can expect:

* **Initial Check-up (Visit 1):** We'll do some tests to make sure you're suitable for the study. You'll also have a trial run of the brain stimulation, called a 'sham' session, which feels like the real thing but doesn't actually stimulate the brain, just to see how you tolerate it. * **Brain Scan and Randomisation (Visit 2):** You'll have an MRI brain scan. After this, you'll be randomly assigned to start with either the 'spaced' or 'compressed' iTBS treatment. * **Treatment Block 1 (Visits 3-5):** Over three separate sessions, you'll receive the first type of iTBS treatment you were assigned. Each session will include safety checks, the iTBS treatment, and measurements of your brain activity and mood. There will then be a break of at least two weeks. * **Treatment Block 2 (Visits 6-8):** After the break, you'll undergo three more sessions, but this time you'll receive the *other* type of iTBS treatment (the one you didn't receive first). Again, each session will involve safety checks, the iTBS treatment, brain activity measurements, and mood questionnaires.

Throughout the study, you'll continue any antidepressant medication you are already on, provided it's at a stable dose. We won't be asking you to change your medication unless your doctor advises it. The total time commitment for all visits and treatments will be roughly 2-3 months.

Potential risks and benefits

Taking part in this study may offer some potential benefits. You might experience an improvement in your depression symptoms, and contributing to this research could help others with depression in the future by advancing our understanding of effective treatments. However, there's no guarantee that you will personally benefit. As with any medical procedure, there are potential risks associated with iTBS, such as mild discomfort at the stimulation site, headaches, or muscle twitching, which are usually temporary. Very rarely, there's a small risk of seizure. All procedures will be explained in detail, and your safety will be monitored closely. You are completely free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

  • Centre for Addiction and Mental Health
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What is iTBS?

iTBS is a gentle brain stimulation treatment that uses magnetic pulses to encourage changes in brain activity and improve connections in the brain.

Will I feel anything during the treatment?

You might feel a tapping sensation on your scalp during the treatment, but it's generally well-tolerated. We'll check how you feel during a 'sham' session first.

Will I have to stop my antidepressants?

No, you will keep taking your current antidepressant medication at a stable dose throughout the study. We won't ask you to change it.

How long does each treatment session last?

One of the benefits of iTBS is that each treatment session is quite short, lasting only about 3 minutes, much quicker than some other similar treatments.

What is 'brain plasticity'?

Brain plasticity is your brain's amazing ability to change, adapt, and form new connections. We believe improving this can help with depression.

How to find out more

Christoph Zrenner, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Theta-Burst Stimulation to Treat Depression…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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