DISCOVER THE ONLY FDA APPROVED LONG-TERM TREATMENT OPTION FOR DEPRESSION
(Adapted from Out of the Black Hole: The Patient’s Guide to Vagus Nerve Stimulation and Depression-Copyright 2006)

Everybody has a story. My story is the one I know best and can write about. It is not a memoir of chemical dependency or self-abuse. Those subjects have been written about many times. This is a story of my winning battle against depression and the vagus nerve stimulation (VNS) treatment that saved my life by bringing me Out of the Black Hole. And, this is the first book to be published about winning the battle with a medical implant procedure called VNS Therapy TM.

The U.S. Food and Drug Administration (FDA) recently approved vagus nerve stimulation “for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.” Cyberonics, the manufacturer of the VNS Therapy System TM is in the process of educating psychiatrists nationwide about the first ever FDA-approved informatively labeled, long-term treatment option for the lifelong and life-threatening illness of depression.

Prior to vagus nerve stimulation therapy, I had tried countless antidepressants/antidepressants combinations, eighteen ECT treatments and 20 plus years of psychotherapy. But nothing worked. My depression became more severe, longer in duration and more difficult to recover from, until I never could recover. In November of 2001, I accidentally and luckily discovered that the manufacturer of the vagus nerve stimulator had been given FDA approval to conduct a Phase III, pivotal investigational trial of vagus nerve stimulation to treat chronic or severe depression. It was a life-changing, life-saving discovery. The results of this trial would ultimately be submitted to the U.S. Food and Drug Administration (FDA) to determine the efficacy and safety of the procedure.

In order to meet FDA guidelines, there were twenty-two study sites spread across the country, with an average of nine patients per site. The trial was designed to include only the most severe and difficult to treat patient population suffering from depression. No other clinical trial had ever studied this difficult to treat patient group. This was truly a pioneering study. Here are a few of the characteristics* of the average patient in the trial:

Average Age: 46 years old
64% Female and 36% Male
Baseline Depression Rating: Moderate-Severe
Duration of Lifetime Illness: 25 years
Duration of Current Episode: 4.6 years
Number of Failed Treatments: 7

*Source: Presentation to FDA Advisory Panel on June 15, 2004

I certainly fit within all of the average characteristics, including a baseline depression rating of “severe”?. Depression had slowly taken over my life. I went from being a Wall Street executive to someone who was afraid to leave my home. I lived in a prison without bars. Depression hurt both physically and mentally. I had aggressively tried every available therapy for over twenty years, but the depression kept getting worse. I lived a life of utter despair and misery. Although I had never even heard of the vagus nerve, I was willing to try anything that could potentially rescue me from the grips of this biological, disabling and life-threatening disease. It took four months to be approved for inclusion in the study. The study investigators had to review all of my medical records, hospitalizations and medicines. I kept waiting for the phone call from the study site to tell me that I had been approved as a study subject. Finally, I got the call that was “in.”? I didn’t know what I was in for, but I was in. I had the opportunity to benefit from a potentially medical breakthrough treatment for my incurable disease that was ruining my life. I was willing to try anything. I had nothing to lose. In April of 2001, I was implanted with the VNS Therapy Systemâ„¢. The therapy completely changed my life in too many ways to describe in one article. There is no article long enough to express my gratitude for this treatment. I am so humbled and thankful for this life-changing procedure. Vagus nerve stimulation is not for everyone and is not a guaranteed cure for depression. You must strictly follow the directives of your doctor.

Four Important Things to Know About Vagus Nerve Stimulation for Depression

1. What is the Vagus Nerve?

   Vagus means “wandering”? in Latin, and is the perfect description for the vagus nerve, the longest nerve in the body. It averages almost two feet in length and “wanders”? throughout the upper body. The vagus nerve starts in the brain, goes down the neck and into the body where if affects the vocal cords, the acid content of the stomach, the heart, the lungs, and other organs. In the brain it projects to areas believed to be responsible for seizures, mood, appetite, memory and anxiety. However, the vagus nerve cord does not have many pain nerves, so stimulation of the vagus nerve is not painful, although some patients may feel some sensation when electrical pulses are generated.

2. What is Vagus Nerve Stimulation?

   VNS is not related to brain surgery or ECT, although it is a treatment that affects the function of the brain. Vagus Nerve Stimulation uses specific stimulation of the vagus nerve to send stimulation to specific parts of the brain that are involved in mood. It is not like electro-convulsive Therapy (ECT), a treatment that involves stimulation of the entire brain and induces convulsions in patients. In fact, patients may not even feel the stimulation from VNS since the vagus nerve does not have the type of nerves that carry pain signals. Nor does VNS interfere with drugs, so patients having vagus nerve stimulation can continue taking their other drugs without worrying about side effects or interactions between drugs.

3. How Does Vagus Nerve Stimulation Therapy work?

   The VNS Therapy Systemâ„¢ is implanted in the patient’s upper left chest. One lead wire is tunneled underneath the patient’s chest and coiled around the left vagus nerve is the neck. The two inch incision is made at the lowest fold of the neck. No surgical activity takes place near the brain. The Pulse Generator delivers a small amount of electrical current to the vagus nerve intermittently (30 seconds on and five minutes off ) 24 hours a day, 7 days a week for up to 10 years. The stimulation is delivered automatically, so the patient does not have to do anything. Because there is nothing to remember, compliance is assured. The stimulation is not supposed to be uncomfortable, and some patients do not even feel the stimulation. A nurse at the doctor’s office can adjust the level of stimulation (amount of electricity delivered) if the patient ever feels uncomfortable. In the study currently being reviewed by the FDA, researchers noted several similarities between epileptic and depressed patients. One of the most important benefits of vagus nerve stimulation treatment is that efficacy improves over time. The longer the patient receives stimulation, the better the results. In addition, the study patients all shared the following benefits: Assured adherence to treatment regimen Safety of the procedure-over 40,000 patients have safely had the identical therapy for epilepsy

   • No cognitive impairment( i.e. memory loss)
   • High continuation rates
   • No drug interactions
4. How Do I Obtain Access to This Treatment?

   Vagus nerve stimulation therapy is now an FDA approved procedure for chronic or treatment-resistant depression. You will need a prescription from your psychiatrist for the procedure. The ninety-minute out-patient procedure can be performed by a neurosurgeon, vascular surgeon or ENT. I strongly recommend that patients choose a surgeon who has specific experience operating within the carotid sheath. The vagus nerve lies deep and in between the common carotid artery and the jugular vein. The implant is performed under general anesthesia and the patient usually goes home that same day. VNS Therapyâ„¢ is not a guaranteed cure for depression. There are no guaranteed cures for depression. According to the data published on the FDA’s web site, over 50% of the study patients experienced at least a clinically meaningful, highly meaningful or extraordinary meaningful response the therapy. In my opinion, neuromodulation is the next frontier in the treatment of many chronic diseases such as depression. My hope is that you have access to VNS Therapyâ„¢ and that VNS Therapyâ„¢ works for you in the treatment of this baffling and debilitating disease.

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