RecruitingNAINTERVENTIONAL

Patient-oriented Randomized Pragmatic Feasibility Trial with RTMS in Depression and Anxiety

This research study is looking at a type of brain stimulation treatment called Repetitive Transcranial Magnetic Stimulation (rTMS) for people experiencing severe depression and anxiety. Specifically, it's for those whose depression hasn't improved with other treatments, sometimes called 'treatment-resistant depression.' We're comparing two different ways of giving rTMS to see which might be more effective and better tolerated. The main goal is to figure out if it's practical to do a larger study of this treatment in the future. We're also asking patients for their thoughts on various parts of the study, like how we measure symptoms and how we could use technology to understand their progress better. This will help us design the best possible future research.

At a glance

Status

Recruiting

Phase

Sponsor

University of British Columbia

Enrolment target

100

Start

11 Oct 2021

Estimated completion

01 Aug 2025

Major Depressive Episode Major Depressive Disorder

What is this study about?

This research study is about finding better ways to help people who have serious depression and anxiety, especially when other treatments haven't worked well for them. This is often called 'treatment-resistant depression.' We are focusing on a treatment called Repetitive Transcranial Magnetic Stimulation (rTMS), which uses magnetic pulses to gently stimulate specific areas of the brain.

In this study, we're not just trying to see if rTMS works, but also how best to study it in the future. We're comparing two slightly different ways of giving the rTMS treatment. We also want to understand what's important to patients, for example, how they feel about different ways of tracking their mood and progress, and if they would be open to using digital tools, like smartphone apps, to help measure their well-being. Your feedback is crucial for making future studies more patient-friendly and effective.

The information we gather from this study will help us decide if we should do a bigger, more definite study on rTMS. It will also help us design that future study in a way that truly benefits patients, by understanding their preferences and making sure the research is as practical and helpful as possible.

Key takeaways

This study explores a brain stimulation treatment (rTMS) for severe depression and anxiety.
It's for people whose depression hasn't responded to other treatments.
The study compares two different ways of giving rTMS.
Patient feedback is important for designing future larger studies.
Participants will receive rTMS treatment and complete mood assessments.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who are experiencing moderate to severe depression. You need to be an outpatient, meaning you're not staying in a hospital for your mental health treatment, and able to understand and agree to take part in the study.

There are a few other important things. You should not have started any new mental health medications or changed the dose of existing ones in the last four weeks. You also need to be able to stick to the treatment schedule. Before taking part, you'll have a safety check to make sure TMS treatment is safe for you.

However, this study isn't suitable for everyone. For example, if you have thoughts of harming yourself, are pregnant, or have conditions like schizophrenia or bipolar I disorder, you wouldn't be able to join. Also, if you have certain metal implants in your head, a history of seizures, or significant memory problems, this study wouldn't be right for you. Your study doctor will discuss all the requirements with you to see if you're a good fit.

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 18 years old or older?
Do you have moderate to severe depression where other treatments haven't worked?
Have you been on a stable dose of your mental health medication (or no new medication) for at least the last 4 weeks?
Are you able to attend appointments regularly?
Do you *not* have a history of seizures or certain metal implants in your head?
Are you *not* currently pregnant or having thoughts of harming yourself?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive a course of rTMS treatment. The specific details of how many sessions and over what period will be explained to you. You'll have regular appointments to receive the treatment and some additional visits for assessments. These assessments will involve completing questionnaires about your mood and anxiety, some of which will be filled out by you and some by a healthcare professional.

You'll also be asked for your opinions and preferences on different aspects of the study, such as how your symptoms are measured and whether you would be comfortable using digital tools, like smartphone apps, to track your health. The total time you'd be involved in the study hasn't been specified, but it would involve attending treatment sessions and follow-up assessments.

Potential risks and benefits

Taking part in a research study has potential benefits and risks. You might benefit from receiving a new treatment that could help improve your depression and anxiety symptoms. This treatment might be more effective for you than previous ones. However, as with any medical treatment, there's no guarantee that it will work for everyone, and you might not feel better. Possible side effects of rTMS are generally mild and can include a headache, scalp discomfort, or facial twitching during the treatment. Rarely, more serious side effects like seizures can occur. All possible risks will be fully explained to you by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Non-Invasive Neurostimulation Therapies (NINET) Laboratory, UBC Department of Psychiatry
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is rTMS treatment?

rTMS stands for Repetitive Transcranial Magnetic Stimulation. It's a non-invasive treatment that uses magnetic pulses to stimulate specific areas of the brain that are involved in mood.

Who is this study for?

This study is for adults aged 18 and over who have moderate to severe depression that hasn't improved with other treatments.

Will I have to stay in hospital?

No, this study is for outpatients, meaning you will attend appointments but not stay overnight in a hospital.

What happens if I want to stop participating?

You are free to leave the study at any time, for any reason, without it affecting your medical care.

Will I know which type of rTMS I am getting?

The study compares two types of rTMS; the study team will explain the details of the specific treatment you would receive.

How to find out more

Jessica Layton

ninet.lab@ubc.ca 604-822-7308 Official trial record

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