Active not recruitingNAINTERVENTIONAL

Neural Mechanisms of Intermittent Theta Burst Stimulation in the Core Depression Network

This research is investigating a new type of brain treatment for depression called intermittent theta burst stimulation (iTBS). Unlike standard treatments that can take longer, iTBS is very quick, lasting only about 3 minutes per session. The study aims to understand precisely how iTBS works on the brain, particularly in areas linked to depression. Researchers will use special brain scans (PET and MRI) to see how iTBS changes brain activity in people with major depression. Participants will receive both iTBS and a dummy (sham) treatment, then a full course of iTBS, all while closely monitoring their brain and mood. This will help scientists learn if this fast treatment could be a powerful new option for depression.

At a glance

Status

Active not recruiting

Phase

Sponsor

The Royal Ottawa Mental Health Centre

Enrolment target

Start

26 Apr 2023

Estimated completion

03 Jan 2027

Major Depressive Disorder

What is this study about?

This study is exploring a new way to treat major depression using a technique called intermittent theta burst stimulation (iTBS). You might have heard of similar treatments that use magnetic fields to gently stimulate the brain. iTBS is a newer, faster version of this. Traditional brain stimulation sessions for depression can last about 30-45 minutes, but iTBS is much quicker, taking only about 3 minutes.

The main goal of this research is to understand exactly how iTBS affects the brain. While we know it can be a promising treatment, researchers want to see what changes happen inside the brain, especially in areas thought to be involved with depression. They will use advanced brain imaging techniques, like PET scans and MRI scans, to get a detailed picture of brain activity and structure before, during, and after treatment.

Participants will start by receiving both the real iTBS and a dummy (sham) treatment without knowing which one they are getting (this is called 'double-blind'). This helps researchers compare the true effects of iTBS. After this initial comparison, everyone will receive a full, daily course of iTBS over several weeks. By carefully observing brain changes and mood, the study hopes to show how this fast treatment works and if it can effectively help people with depression.

Key takeaways

Exploring a fast, new brain stimulation treatment for depression.
Uses advanced brain scans (PET, MRI) to see how the brain changes.
Compares active treatment to a dummy treatment.
Six-week daily treatment course of iTBS follows the comparison.
Aims to understand how iTBS works to improve depression.
Could help develop more effective and quicker depression treatments.

Who may be eligible?

This study is looking for men and women between the ages of 18 and 55 who have been diagnosed with major depression. You should have tried at least one, but no more than seven, different antidepressant medications without enough improvement in your current depressive episode. Your depression symptoms should be noticeable, as measured by a standard questionnaire.

It's important that your antidepressant medication has been stable for at least a month before starting the study. You also need to be able to speak and read English. Certain health conditions or treatments might mean you can't take part. For example, if you've recently had a suicide attempt, are pregnant or breastfeeding, or have certain other mental health conditions like bipolar disorder or a history of psychosis, you would not be able to join. Your general health will also be checked to make sure you're well enough for the study.

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.

Are you between 18 and 55 years old?
Have you been diagnosed with major depression?
Have you tried 1 to 7 antidepressant medications without enough improvement?
Has your current antidepressant dose been stable for at least 4 weeks?
Are you able to speak and read English?
Do you have any metal implants (e.g., pacemaker) or a history of seizures?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you would first go through screening to ensure you meet all the study criteria. This usually involves health checks, questionnaires about your mood and medical history, and possibly urine tests and blood tests. You’ll also have brain scans (PET and MRI) to get a baseline picture of your brain activity.

The main part of the study involves receiving treatments. You would have several sessions where you receive either active iTBS or a dummy (sham) treatment. You won't know which one you are getting at the time. After this, you would then receive a full course of daily iTBS treatments for about six weeks. Throughout the study, you'll have regular check-ups, more brain scans, and your mood will be monitored. You will stay on your stable antidepressant medication throughout the study. The total duration of your active involvement in the study, including scans and treatments, would likely span several weeks to a few months.

Potential risks and benefits

Patients in this study might benefit from receiving a new and potentially effective treatment for depression (iTBS) which could improve their symptoms. They also contribute valuable information that could help others in the future. However, like all medical treatments, there are potential risks. iTBS, while generally safe, might cause some temporary side effects like headaches or mild discomfort at the stimulation site. There's also the risk associated with brain scans, such as exposure to radiation from PET scans, though these are carefully monitored. It's crucial to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

The Royal Ottawa Mental Health Centre
Verified postcode
Ottawa, Canada

Common questions

What is iTBS?

iTBS is a new, quick type of brain stimulation that uses magnetic pulses to gently influence brain activity, similar to a standard treatment called rTMS, but much faster.

How long does an iTBS treatment session take?

Compared to older methods that can take 30-45 minutes, a single iTBS treatment session typically only takes about 3 minutes.

What are PET and MRI scans for?

These are special brain scans used to get detailed pictures of your brain's structure and how it's working, helping researchers understand how iTBS affects it.

Will I know if I'm getting the real treatment or the dummy treatment?

No, initially you won't know, nor will the study staff. This is to ensure the most accurate comparison between the real treatment and the dummy treatment.

Can I take part if I'm on antidepressants?

Yes, if your antidepressant medication has been stable for at least four weeks before the study, you may still be eligible to participate.