A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
Doctors in the UK are conducting a study to understand the effectiveness and safety of a treatment called Vagus Nerve Stimulation (VNS) therapy for individuals struggling with depression that has been difficult to treat. This often means standard medications or talking therapies haven't worked well enough. The study aims to follow at least 500 patients over several years after they have a small device implanted, which delivers gentle electrical pulses to a nerve in the neck. Researchers will monitor their mental well-being and general health, gathering information on how VNS therapy might help over the short, medium, and long term. This research will help doctors understand if VNS could be a valuable additional treatment option for severe depression.
At a glance
What is this study about?
This research study is looking into a treatment called Vagus Nerve Stimulation, or VNS therapy. It's designed for people in the UK who have severe depression that hasn't gotten better with other common treatments, such as different medications or therapies. This kind of depression is often referred to as 'difficult-to-treat' or 'treatment-resistant' depression. The study wants to see how well VNS therapy works as an 'add-on' treatment, meaning it's used alongside their usual depression care.
The main goal is to understand the effects of VNS therapy over time – in the short term, after a few months, and over several years. Researchers will be observing whether it helps to improve symptoms of depression and how people feel in their daily lives. They are particularly interested in individuals who have experienced depression for a long time (chronic) or have had several episodes (recurrent), whether they have unipolar depression or bipolar disorder.
The study plans to involve at least 500 patients across about 80 different medical centres. Each patient will have a small, pager-sized device implanted under the skin in their chest, with a thin wire connected to the vagus nerve in their neck. This device sends gentle electrical pulses. Researchers will then closely follow these patients for at least three years, and potentially up to five years, to carefully track their progress and the effects of the VNS therapy.
Key takeaways
- This study investigates VNS therapy for severe, difficult-to-treat depression.
- It aims to see how well VNS works over several years as an add-on treatment.
- Participation involves a small device implant and long-term follow-up appointments.
- Focuses on adults (18+) with chronic or recurrent depression.
- You must be currently receiving other depression treatments to be eligible.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. You must have a clear diagnosis of major depression that has lasted for more than two years, or you've had at least two previous episodes of depression, and it hasn't responded well to standard treatments. A specific interview will be used to confirm your diagnosis.
You also need to be currently receiving some form of treatment for your depression, which could be an antidepressant medication, ongoing electroconvulsive therapy (ECT), or regular talking therapy. If you have bipolar disorder, you should be on mood-stabilising medication like lithium.
It's important that you are able and willing to attend regular clinic appointments and complete all the necessary assessments throughout the study. However, this study might not be suitable if you have certain other conditions, such as significant learning difficulties, current severe drug or alcohol problems, specific psychotic disorders like schizophrenia, or certain severe personality disorders that might make it hard to take part fully.
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?
- Have you had depression that's lasted over 2 years, or had 2+ past episodes that didn't respond well to other treatments?
- Are you currently receiving treatment for your depression (medication, talking therapy, or ECT)?
- Are you able and willing to attend regular clinic appointments for several years?
What does participation involve?
If you join this study, your journey will involve several stages. First, there will be an initial assessment visit about 1 to 6 weeks before the VNS device is implanted. During this visit, checks will be done to confirm your eligibility and gather baseline information.
After the device is implanted, you will have regular follow-up appointments. These visits are crucial for the doctors to monitor your progress, check the device, and adjust its settings if needed. You will be followed for a minimum of 36 months (3 years) and potentially up to 60 months (5 years) after getting the device. Throughout this time, you will need to attend these outpatient clinic visits and reliably complete various evaluations as requested by the study team. The overall enrolment for new patients into the study is expected to last for 8 years.
Potential risks and benefits
Locations (18)
- AKH Allgemeines Krankenhaus der Stadt WienVerified postcodeVienna, Austria· Recruiting
- KU LeuvenVerified postcodeLeuven, Belgium· Recruiting
- Sozialstiftung Bamberg - Klinikum am BruderwaldVerified postcodeBamberg, Germany· Withdrawn
- Universitätsklinikum BonnVerified postcodeBonn, Germany· Recruiting
- Universitätsklinikum KölnVerified postcodeCologne, Germany· Recruiting
- LVR-Hospital EssenVerified postcodeEssen, Germany· Recruiting
- Universitätsklinikum FrankfurtVerified postcodeFrankfurt, Germany· Recruiting
- Universitätsklinikum FreiburgVerified postcodeFreiburg im Breisgau, Germany· Completed
- Universitätsmedizin GöttingenVerified postcodeGöttingen, Germany· Withdrawn
- Medizinische Hochschule HannoverVerified postcodeHanover, Germany· Withdrawn
- Universitätsklinikum JenaVerified postcodeJena, Germany· Completed
- Universitätsklinik LeipzigVerified postcodeLeipzig, Germany· Recruiting
Common questions
What is Vagus Nerve Stimulation (VNS) therapy?
VNS therapy involves a small device, like a pacemaker, that's surgically placed under the skin in your chest. It sends mild electrical pulses through a thin wire to a nerve in your neck called the vagus nerve, which can affect mood.
Is this a new treatment?
VNS therapy has been used for some time for certain conditions. This study is specifically looking at how well it works as an additional treatment for difficult-to-treat depression in a real-world setting.
What if I'm already on other depression treatments?
To be eligible, you actually need to be currently receiving at least one ongoing treatment for your depression, such as medication, ECT (electroconvulsive therapy), or talking therapy. VNS therapy in this study is used as an 'add-on' to your existing care.
How long will I be involved in the study?
If you join, you'll be followed for at least 3 years, and possibly up to 5 years, after the VNS device is implanted. This involves regular check-ups.
Do I have to move to take part?
No, the study will have sites across the UK. You would attend appointments at one of the participating medical centres near you, if available, for your follow-up care.
How to find out more
Funda Basdar
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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