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.
VNS Therapy was approved by the FDA as a safe and effective treatment option for treatment resistant depression in 2005. It has been tested in a number of research studies and prescribed for more than 4,000 depression patients across the United States, which means doctors and patients already have a lot of experience with it.
In an early clinical trial called the D-02 study, 235 patients with treatment resistant depression had a VNS device implanted. After a year, a third of all the patients in the trial had benefitted from VNS Therapy and over half of them had fully (or almost fully) recovered from depression. Based on this evidence, the FDA approved VNS Therapy as a safe and effective treatment option for treatment resistant depression.
However, even though VNS Therapy is FDA-approved and has been shown to help people with treatment resistant depression, Medicare is only covering it for patients enrolled in the RECOVER study and other insurers do not routinely cover it.
The RECOVER study was designed in partnership with many of the nation’s top experts in treatment resistant depression, and approved by Medicare, to provide additional evidence of the benefit of VNS Therapy for patients with depression. If the results confirm previous studies, this may provide the evidence needed for Medicare and other insurers to start to cover it.
To join the RECOVER Study, you must be 18 years or older and:
Depression, and bipolar depression, are complex medical conditions that cause people to have excessive and intense feelings of sadness and hopelessness for extended periods of time.
Depression is one of the most common medical conditions in the United States, affecting 7% of the adult population.6
The exact cause of depression is not known, however there are several factors that may contribute or trigger an episode of depression such as genetics, emotional stress and/or traumatic events (a combination of genes and stress can affect brain chemistry and increase the risk of depression), alcohol or drug abuse, and other medical conditions such as cancer or hypothyroidism. Changes in the balance of hormones might also contribute to the development of depression.3
People who have depression typically have more than one episode during their life. Symptoms vary person-to-person, but often include:3
Depression is well-researched, and, with ongoing treatment and support, it is possible to recover.
However, one out of three people with depression have what is called ‘treatment resistant’ depression, also referred to as ‘difficult-to-treat’ depression which means they have tried several treatments without success.1
The RECOVER Study is a research study that will provide new information about how helpful VNS Therapy is for patients with treatment resistant depression, and bipolar depression.
VNS stands for ‘Vagus Nerve Stimulation’. VNS Therapy is an approved treatment for people with depression, and bipolar depression, who have not been helped enough by several other types of treatment, such as antidepressant medications (pills and tablets), psychotherapy (talk therapy), repetitive trans-magnetic stimulation (rTMS) and electroconvulsive therapy (ECT).
The way VNS Therapy works is that a small device is placed just below your collarbone, by a trained surgeon during a short outpatient procedure. The device sends out mild pulses to a nerve in your neck called the vagus nerve. From there, these pulses travel up to your brain and can help to improve how you are feeling.
Over the past 15 years, many doctors have come to believe that VNS Therapy is a good option for people with treatment resistant depression, who haven’t found other more common treatments for depression helpful.4
However, even though VNS Therapy is FDA-approved and has been shown to help many people with treatment resistant depression, Medicare will only cover it through the RECOVER study and other insurers do not routinely cover it.
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 will last approximately 12 months, with an additional long-term follow-up period of four years. It will include at least 22 visits to a study clinic in your location during that time. At these visits you will undergo various assessments and complete questionnaires to assess how you are feeling and your overall health. As the first step you will be invited to visit a study clinic in your location where you will be given details about the study and the medical team will see if you qualify and assess if the study is right for you.
If you join the study, you will need to have a short outpatient surgical procedure to place the VNS device just under the skin below your collarbone and connect it to the vagus nerve in your neck. You will probably be able to go home the same day.
Participants in the study will be divided into two groups, Group A and Group B. There is an equal chance of being in Group A or B and no one, including your doctor, will know which group they are in. Your group will be chosen by random, like flipping a coin.
During the first 12 months of the study, you will be asked to visit the study center regularly, no matter which group you are put in. The first few visits will be to ensure the study is suitable for you, to assess your current mood and health, and to adjust the device settings. At later visits, you will be asked to fill out questionnaires and answer questions about your mood, health, and daily life. You will also be asked about your experience with VNS Therapy.
VNS Therapy and all study-related care will be provided at no cost to you and you will receive compensation for each study visit you complete.
You can continue to see your current psychiatrist or regular physician for routine care outside of the study. It is best for your current treatments not to be changed during the first 12 months of the study, but if your doctor does decide to change them, it is important to let the study staff know.
Please note: if you are woman who is able to become pregnant, you will need to use a reliable method of birth control throughout the study to avoid a pregnancy.
Your rights as a study participant
Choosing to take part in the RECOVER Study is entirely your decision. You will still be entitled to receive your usual medical care, whatever you decide.
Here are some things to think about if you are considering joining the RECOVER Study: Benefits
Risks / drawbacks
What happens if I Sign Up? If you think you might like to join the RECOVER Study or would like more information, please enter your information below so we can see if you qualify.
If you qualify, we will match you to a study clinic in your area that is seeking participants or notify you when a study clinic becomes available. The study team will contact you to explain more about the study before you make your decision about participating. You will attend an in-person visit where the study team will help determine if you qualify and if the study is right for you.
This Screening tool is for US residents only. If you are not a US resident, please do not complete this form.
If you are a Health Care Provider that would like more information about the RECOVER clinical study, or if you would like to refer a patient, please enter your information below and one of our LivaNova representatives will contact you as soon as possible.