If bipolar depression is deep enough to isolate you from life… THERE IS HOPE.

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If you have been suffering from an episode of bipolar depression and have been unsuccessful finding a treatment that is helpful, you may qualify to take part in the RECOVER Study.

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A new research study for people with treatment resistant bipolar depression.

GET STARTED – SEE IF YOU QUALIFY

* 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.

The recover study

One out of three people with depression or bipolar depression have tried several treatments without success. This is called ‘treatment resistant’, or ‘difficult-to-treat’ depression.

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 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, 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 benefited 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 bipolar depression. If the results confirm previous studies, this may provide the evidence needed for Medicare and other insurers to start to cover it.

If you are over the age of 18 and have been suffering from 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.

CHECK IF YOU QUALIFY

Up to 500 people who have bipolar depression that has been hard to treat will take part in the study.

The study will be done 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?

CHECK IF YOU QUALIFY

To join the RECOVER Study, you must:

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Be 18 years or older,

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Currently be depressed,

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Have bipolar depression that has lasted for at least two years or recurred several times,

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Have tried at least four treatments and not found them helpful, and

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Be receiving at least one mood stabilizing medication.

About depression

Bipolar depression is a complex medical condition that causes people to have excessive and intense feelings of sadness and hopelessness for extended periods of time.

Bipolar depression impacts 4% of the adult population in the United States at some point in their lives.¹

The exact cause of bipolar depression is not known, however there are several factors that may contribute to 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.²

Mental health

Vitality

Emotional Wellbeing

Social Functioning

People who have bipolar depression typically have more than one episode during their life. Symptoms vary person-to-person, but often include:³

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Feeling sad, empty or hopeless

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Outbursts of anger, irritability or frustration

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Loss of interest in life and usual activities

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Sleep disturbances

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Tiredness or lack of energy

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Reduced appetite/increased appetite

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Feeling worthless

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Unexplained physical problems

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Inability to concentrate

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Thoughts of death or suicide

Bipolar depression is well-researched, and, with ongoing treatment and support, it is possible to recover.However, one out of three people with depression have tried several treatments without success. This is called ‘treatment resistant’, or ‘difficult-to-treat’ depression.

The RECOVER Study is a research study that will provide new information about how helpful VNS Therapy is for patients with treatment resistant bipolar depression.

CHECK IF YOU QUALIFY

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.

CHECK IF YOU QUALIFY

Results with VNS Therapy get stronger over time³

In a 5-year study of 795 patients with Treatment-Resistant Depression (TRD), results were superior with VNS Therapy + traditional treatment compared to traditional treatment alone.⁴

These results included quality of life improvements that lasted over the 5-year study period.^4,11

People who added VNS Therapy to their traditional treatments also had sexual function scores that improved each year for 5 years and were 2X less likely to have suicidal thoughts than those using traditional treatments alone.⁴

Sexual Function

Vitality

Emotional Well-being

Mental Health

Social Functioning

A separate analysis of bipolar patients treated with VNS Therapy + traditional treatment compared to traditional treatment alone found that:⁴

patients experienced reduction

in depression symptoms⁶

full or almost fully recovered

from their depression symptoms⁵

VNS Therapy™ is safe and well tolerated

VNS Therapy is not a drug^3,7,8,9

Does not cause the same side effects that antidepressant medications cancause, including:

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Fatigue

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Sedation

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Weight gain

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Dry Mouth

Does not cause the same side effects as other medication-free treatments can cause (e.g., ECT, TMS) including:

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Memory loss

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Drowsiness

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Poor concentration

The most common side effects of VNS Therapy include voice changes (hoarseness), prickling or tingling in the skin, sore throat, increased coughing, shortness of breath.Side effects typically occur only when the pulses are being transmitted, and are noticed less as time goes on.¹⁰

CHECK IF YOU QUALIFY

FAQs

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.

What can you expect from the RECOVER Study?

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.

In order to participate in the study you will need to continue use of a mood stabilizing medication as well as your usual anti-depressant treatment.

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.