If depression is deep enough to isolate you from life…
THERE IS HOPE.
If you have been suffering from an episode of depression, or bipolar depression, and have been unsuccessful finding a treatment that is helpful, you may qualify to take part in the RECOVER Study.
* As a study participant, all study-related care will be provided at no cost to you and you will receive compensation for each study visit you complete.
What is a Clinical research study?
A clinical research study (also called a clinical trial) is a medical study that helps to answer important questions about a drug or device, such as: ‘How well does it work?’, ‘Does it cause side effects?’ or ‘How effective is it compared to another drug/device?’ Some clinical trials investigate new treatments, while others, like the RECOVER study, seek to gain more information about a treatment that has already been approved by the FDA and prescribed to patients.
The RECOVER Study
One out of three people with depression, or bipolar depression, have what is called ‘treatment resistant’ depression, or ‘difficult-to-treat’ depression. This means they have tried several treatments without success.
Even if several types of treatment haven’t worked for you – or have not worked well enough – there is still a chance that something else will.
The RECOVER Study is a research study that will provide new information about how helpful the VNS (Vagus Nerve Stimulation) Therapy® System is for patients with treatment resistant depression.
Health Condition: Treatment-resistant depression and bipolar depression
Who can participate: Adults 18 years and older
FDA approved treatment: Yes
Reason to participate: By joining you have a chance to get help from a depression treatment that is not generally available.
You might also be helping other people get this treatment in the future.
The purpose of the RECOVER Study
The RECOVER study is a new research study for people with difficult to treat depression.
The study will gather more information about how helpful the VNS Therapy is for patients with depression that has been difficult to treat.
VNS Therapy was first approved by the FDA as a safe and effective treatment choice for depression in 2005. It has been tested in several research studies and prescribed for more than 4,000 depression patients across the United States.
Benefits of VNS Therapy
Results with VNS Therapy + traditional treatment are better than with traditional treatment alone.
- 7 in 10 people significantly improved with VNS Therapy
- 4 in 10 people fully or almost fully recovered
- 2X less likely to have suicidal thoughts
- Improved sexual function
- Improved quality of life
About the RECOVER Study
Although VNS Therapy is FDA-approved and has been shown to help people with treatment-resistant depression, Medicare only covers it for patients enrolled in the RECOVER study, and other insurance companies don’t always cover it.
To change this, many of the nation’s top depression experts worked together to help design the RECOVER study. If the results are like past studies, this may provide the proof Medicare and insurance companies need to start to cover it.
Up to 1,000 people who have depression or bipolar depression that has been hard to treat will take part in the study.
You will receive compensation for each study visit you complete.
By joining, you could help many other people with treatment–resistant depression get VNS Therapy in the future.
Things to consider if you join
By joining the RECOVER study, you have a chance to get help from an FDA-approved treatment for your depression that is not generally available unless you pay for it yourself.
By joining, there is a chance that your symptoms of depression will get better, or even go away. Your quality of life may get better.
Once started, you will receive an ongoing treatment for depression that’s with you 24/7.
By taking part in the study, you might also be helping other people like you to get this treatment in the future.
If you are in Group A of the study, your VNS device will be turned on from the start. After 12 months, patients in both groups will have their VNS device turned on for the remaining 4 years of the study.
Being in a research study may mean you will get more healthcare than you would get outside of a study. For some people, this increased attention can be helpful.
You can still use your usual medication or therapies.
There is a 50/50 chance you will be in Group B. This means that, although you will receive a VNS device, you will not be treated for the first 12 months of the study.
Using the device may cause side effects (unwanted changes in your health). Side effects are a risk with all medical treatments. The most common side effects from using the device include voice changes (hoarseness), prickling or tingling in the skin, sore throat, and shortness of breath. These tend to get better over time.
You’ll need a short outpatient operation to implant the device. The most common side effect from putting in the device is infection (<1%)