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FDA Approves New Therapy for Depression

By Charles E. Donovan

On July 18, 2005, the FDA approved vagus nerve stimulation therapy as a treatment for chronic depression. This is the first ever FDA-approved long term treatment option for sufferers of treatment-resistant depression(TRD). Over four million Americans suffer from TRD.

I was a study patient in the investigational clinical trial of vagus nerve stimulation and depression.

Just over four years ago, I sat in the Psychiatrist's office at the study site (there were 20 different sites around the United States) that was conducting the investigational clinical trial for vagus nerve stimulation as a therapy for chronic or treatment-resistant depression. I had found about the study completely by accident. I was desperate (not suicidal). I had gone through the merry-go-around of all available antidepressants/antidepressants combinations, ECT, psychotherapy, etc. I was tired and worn out from living in utter despair.

I had never heard of the vagus nerve (it is the longest nerve in the body, averaging 25 inches in length, passes through the neck and thorax into the abdomen). There were no patient educational materials or anything in the medical literature about vagus nerve stimulation and depression for me to review. The doctor explained to me the procedure, described my obligations as a study subject and that the study was a double-blind, place-controlled study.

Because it was a placebo-controlled study, it meant that I had only a 50% chance of having the device activated, after being implanted, during the acute part of the study (which could last up to six months). I had just two questions: 1) was the procedure safe? and 2) was the procedure related to ECT? Since ECT was not effective for me and was a horrible experience, I didn't want to go through anything like that again. The doctor assured me of the safety of the implant and that it was not in any way related to ECT.

I signed various legal papers including an 11-page consent form. I had nothing to lose. Three and a half months later I was approved to be included in the study and implanted with the VNS Therapy System". The rest, as they say, is history.

I have never been told when the device was activated or ramped up to higher levels of stimulation. Even today, I have no idea of the current level of the device settings.

At some point after being implanted, the device was activated and the level of stimulation was ramped up. Gradually over time my depression and mood improved. I started out at very severely depressed, then severe, moderate/severe, moderate, mild/moderate, mild and then complete remission(although at times my family would probably say that I bypassed remission and went straight to "pain in the ass!"). Obviously, my life has been completely changed by vagus nerve stimulation. I am so humbled and grateful at the good fortune that has been bestowed upon me. I was a goner. And now I'm back. Vagus Nerve Stimulation is not a cure for depression. It is an alternative therapy for patients that have not had an adequate response to traditional antidepressants.

Vagus nerve stimulation is a ninety-minute out patient procedure. It is not related to ECT or brain surgery. There is no cognitive impairmant(i.e. memory loss). A small pacemaker-like device is implanted in the patient's upper left chest and one lead wire is tunneled underneath the patient's skin and coiled around the left vagus nerve. The vagus nerve has a direct pathway to those areas of the brain that are responsible for mood and depression.

A prescription from your psychiatrist will be required for the procedure.

You can learn more about this remarkable treatment at You can sign up for a free newsletter to keep up-to-date on the latest developments.

About The Author

Charles Donovan was a study subject in the investigational trial of vagus nerve stimulation and depression. He is founder of the Web Site. He is author of "Out of the Black Hole: The Patient's Guide to Vagus Nerve Stimulation and Depression". It is available on the Web Site,, Barnes & and 24 hours a day/7 days a week toll free at 1-888-VAGUS-88.


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