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.

The RECOVER Study

  • Up to 1,000 people who have depression or bipolar depression that has been difficult to treat will take part in the study.
  • The study will be carried out at up to 100 leading hospitals and medical centers across the United States.
  • If you choose to participate, you will not have to pay for VNS Therapy or for any study-related care.
  • By participating, you could help many other people with treatment resistant depression to gain access to VNS Therapy in the future.

Who can take part in the RECOVER Study?

To join the RECOVER Study, you must be 18 years or older and:

  • 1
    Currently depressed.
  • 2
    Have depression, or bipolar depression, that has lasted for at least two years or recurred several times.
  • 3
    Have tried at least four treatments and not found them helpful.
If you are over the age of 18 and have been suffering from depression, or bipolar depression, that has lasted at least two years, or has recurred multiple times, you may be eligible to take part in the RECOVER Study.
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Who can take part
VOLUNTEERS WHO TAKE PART IN THE STUDY MAY BE ELIGIBLE TO RECEIVE COMPENSATION FOR THEIR TIME AND TRAVEL.

About Depression

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

  • Feeling sad, empty or hopeless
  • Outbursts of anger, irritability or frustration
  • Loss of interest in life and usual activities
  • Sleep disturbances
  • Tiredness or lack of energy
  • Reduced appetite/increased appetite
  • Feeling worthless
  • Unexplained physical problems
  • Inability to concentrate
  • Thoughts of death or suicide

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.

 

About VNS Therapy

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.

References:
  • 1. Rush AJ et al Am J Psych 2006;163(11): 1905-17
  • 2. VNS Therapy Physician’s Manual, LivaNova
  • 3. DSM-IV Criteria for Major Depressive Disorder (MDD)
  • 4. RECOVER Clinical Study Physician Participation
  • 5. Kaptchuk TJ et al BMJ (2008)
  • 6. National Institute of Mental Health "Major Depression", 2017

Frequently Asked Questions

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 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.

  • All study-related care, including the cost of the VNS Therapy device, will be provided at no cost to you and you will receive compensation for each study visit you complete.
  • All necessary steps will be taken to protect your privacy and confidentiality.
  • Even if you join the study, you are free to leave at any time without having to give a reason. However, the more people who complete the study, the better the chance that the study will provide useful information about VNS Therapy that may help insurers decide to pay for it.
  • The study team will support you in any way they can to make the visits as convenient as possible for you. Your safety and comfort will always be their top priority.

Here are some things to think about if you are considering joining the RECOVER Study: Benefits

  • By joining the RECOVER study, you have a chance of benefiting from an FDA-approved treatment for your depression that is not generally available unless you pay for it yourself.
  • By joining, there is a possibility that your symptoms of depression will improve, or even resolve. You may experience an improved quality of life.
  • Once activated, you will receive a continuous antidepressant therapy that’s always with you.
  • By taking part in the study, you might also be helping other people like you to access 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 four years of the study.
  • Being in a research study may mean you will get more healthcare attention than you would get outside of a study. For some people, this increased attention can be beneficial.5
  • Whichever group you are in, you are can continue to use your usual medication or therapies.

Risks / drawbacks

  • Whichever group you are in, you’ll need a short outpatient surgical procedure to implant the device.2
  • There is a 50/50 chance you will be in Group B. This means that, although you will receive a VNS device, active treatment will be delayed for the the first 12 months of the study.
  • The surgical procedure and stimulation from the device may sometimes cause side effects (unwanted changes in your health).2 Side effects are a risk with all medical treatments. The most common side effects from stimulation include voice changes (hoarseness), prickling or tingling in the skin, sore throat, and shortness of breath. These tend to become less noticeable over time. The most commonly reported side effect from the implantation procedure is infection. The study team will discuss the possible side effects with you but won’t be able predict what side effects you may get and how troublesome these may be.

Sign Up

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.


© LivaNova USA, Inc., a wholly-owned subsidiary of LivaNova PLC.  All rights reserved.  VNS Therapy® is a registered trademark of LivaNova USA, Inc.

Safety Information

CONTRAINDICATIONS The VNS Therapy System should not be used in people who have had the left vagus nerve cut (a left vagotomy). Anyone implanted with the VNS Therapy system CANNOT have any short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy. Injury or damage can occur during diathermy treatment whether the VNS Therapy system is turned “ON” or “OFF.” 

Note: Diagnostic ultrasound is not included in this contraindication. 

WARNINGS VNS Therapy carries some risks. Physicians should inform patients about the warnings, precautions, side effects, and hazards associated with VNS Therapy, including information that VNS Therapy may not be a cure for epilepsy. Since seizures may occur unexpectedly, patients should consult with a physician before engaging in unsupervised activities, such as driving, swimming, and bathing, or in strenuous sports that could harm them or others. The safety and efficacy of VNS Therapy has not been established for uses outside of its approved indications. A malfunction of the VNS Therapy system could cause painful or direct current stimulation, which could result in nerve damage. Patients should use the magnet to stop stimulation if they suspect a malfunction, and contact their physician immediately for further evaluation. Removal or replacement of the VNS Therapy system requires an additional surgical procedure. 

Patients who have pre-existing swallowing, cardiac, or respiratory difficulties (including, but not limited to, obstructive sleep apnea and chronic pulmonary disease) should discuss with their physicians whether VNS Therapy is appropriate for them since there is the possibility that stimulation might worsen their condition. VNS Therapy may also cause new onset sleep apnea in patients who have not previously been diagnosed with this disorder. MRI can be safely performed provided specific guidelines are followed. Patients should contact their physician before scheduling an MRI.

Postoperative bradycardia can occur among patients with certain underlying cardiac arrhythmias.

(AspireSR® and SenTiva® only) Physicians should be informed of any existing heart condition or active treatment for a heart condition (such as beta adrenergic blocker medications). The physician will determine if the Automatic Stimulation feature (also known as AutoStim and Detect & Respond) is appropriate for each patient.

PRECAUTIONS The safety and efficacy of VNS Therapy has not been established for use during pregnancy. Patients who smoke may have an increased risk of laryngeal irritation. There is a risk of infection with the implantation surgery that may require the use of antibiotics to treat or removal of the device. The VNS Therapy system may affect the operation of other implanted devices, such as cardiac pacemakers and implanted defibrillators. Possible effects include sensing problems and inappropriate device responses. If the patient requires concurrent implantable devices, careful programming of each system may be necessary to optimize the patient's benefit from each device.  

(AspireSR® and SenTiva® only) Situations, including but not limited to exercise or physical activity, that cause rapid increases in heart rate may trigger AutoStim if the feature is ON. If this is a concern, patients can talk to their physician about ways to stop stimulation during these situations. Use of the AutoStim Mode (Detect & Respond feature) and/or additional features such as prone position detection and low heart rate detection will result in reduced battery life, which may require more frequent generator replacements. 

(SenTiva® only) Optional time-based features do not automatically adjust for Daylight Savings Time or differing time zones. 

ADVERSE EVENTS  The most commonly reported side effects are hoarseness, sore throat, shortness of breath, and coughing. Other adverse events reported during clinical studies as statistically significant are ataxia (loss of the ability to coordinate muscular movement); dyspepsia (indigestion); hypoesthesia (impaired sense of touch); insomnia (inability to sleep); laryngismus (throat, larynx spasms); nausea; pain; prickling of the skin (paresthesia); pharyngitis (inflammation of the pharynx, throat); and vomiting. These typically occur only during stimulation, are well tolerated and noticed less as time goes on. 

The most commonly reported side effect from the implant procedure is infection. 

*THE INFORMATION CONTAINED IN THIS SUMMARY REPRESENTS PARTIAL EXCERPTS OF IMPORTANT PRESCRIBING INFORMATION TAKEN FROM THE PRODUCT LABELING. THE INFORMATION IS NOT INTENDED TO SERVE AS A SUBSTITUTE FOR A COMPLETE AND THOROUGH UNDERSTANDING OF THE VNS THERAPY SYSTEM NOR DOES THIS INFORMATION REPRESENT FULL DISCLOSURE OF ALL PERTINENT INFORMATION CONCERNING THE USE OF THIS PRODUCT. PATIENTS SHOULD DISCUSS THE RISKS AND BENEFITS OF VNS THERAPY WITH THEIR HEALTHCARE PROVIDER. PRESCRIPTION ONLY - DEVICE RESTRICTED TO USE BY OR ON THE ORDER OF A PHYSICIAN.