| |
| |
|
Depression Information |
|
FDA Nears Completion of Review of Vagus Nerve Stimulation For Chronic Depression
On June 2 at 8:00 pm ET, Reuters news service issued a press release announcing that the FDA have nearly completed final review of the conditions outlined in the February "deemed approvable" letter for VNS Therapy as a treatment for chronic depression. Cyberonics Inc. said that the FDA had nearly completed final review of conditions outlined in the February approval of its implanted device for treatment of chronic depression. The FDA approved the VNS Therapy System pending final labeling, protocols for a post-marketing dosing study and patient registry, as well as resolution of manufacturing issues and any outstanding clinical trial issues. The company said a follow-up inspection of its Houston headquarters will begin on Monday. It also said four manuscripts from clinical trials of the device were accepted for publication in "respected psychiatric peer-reviewed journals." In a statement, Chief Executive Skip Cummins said the company expects to launch sales of the device for "treatment-resistant depression" once minor labeling changes are made and the follow-up inspection has been satisfactorily completed. Cyberonics also said it has entered a formal quiet period with regard to all public communications pending a final FDA decision or other material information requiring disclosure. In a statement, Chief Executive Skip Cummins said the company expects to launch sales of the device for "treatment-resistant depression" once minor labeling changes are made and the follow-up inspection has been satisfactorily completed. Charles Donovan was a patient in the FDA investigational trial for vagus nerve stimulation and depression. After 25 years of chronic depression, vagus nerve stimulation completely cured his chronic depression. The author is so grateful and humbled by this remarkable device. He chronicles is journey in his book Out of The Black Hole: The Patient's Guide to Vagus Nerve Stimulation and Depression Learn more at his website: http://www.VagusNerveStimulator.com
MORE RESOURCES:
Zac Efron loses kid brother, slips into serious depression, and still retains... - Philly2Philly.com
Google News |
|
|
|
RELATED ARTICLES
Are You Someones Puppet? Four Ways People Manipulate Others With the current interest in mental health topics, a mentalhealth language has emerged with words such asmanipulation, boundaries, limits, rescuing, dependence, andcodependence. Many people are unclear what these words meanwhen applied to relationships. First Thing You Should Do to Get Out of Depression Depression, in psychiatry, is a symptom of mood disorder characterized by intense feelings of loss, sadness, hopelessness, failure, and rejection. The two major types of mood disorder are unipolar disorder, also called major depression, and bipolar disorder, whose sufferers are termed manic-depressive. Depression And Celiac Disease Depression is a condition which affects about 15% of the population. Women are more likely to be affected than men. Vagus Nerve Stimulation: What are the Benefits and How Does It Relieve Depression? Vagus nerve stimulation is more effective than antidepressants and is not related to brain surgery or shock treatments. It is a 60-90 minute out-patient procedure, with robust antidepressant affects on the brain. Get Rid Of Depression Once And For All Depression is something that will occur in many people'slives, for various reasons. But the "normal" occurrence ofa plunge in mood due to stressful events in your life,usually doesn't last very long, before a person's naturalresilience responds to the environment of friends andfamily. Mood Disorders And Depression We all suffer with bad moods from time to time. But if you are someone who is in a bad mood or depressed much of the time, take heart. Learn To Take Control of Depression While depression is a growing epidemic in western society, it remains to be one of the most treatable as well. While the medical profession looks first to medication, I believe only the most severe cases require any long-term medical treatment. What Is God Thinking? What can you say to a parent who loses a child to cancer? Whatever words we offer are inadequate to lessen their sorrow. We have no answers to questions like, "Why this child?" or "Why now?" and "What do I do now?"Another question we all ask and cannot answer is, "Where was God and what was He thinking when this horrible thing happened? " For answers, I look to God's written word. Surviving the Storms of Life August in Florida has a daily ritual that Floridians take with a grain of salt. It's the daily storms that pass by and that are filled with more electricity than in a 4th of July fire works display. Efficacy and Safety of Vagus Nerve Stimulation for Depression Published in Journal On September 1st, the efficacy and safety of vagus nerve stimulation for depresssion was published in the prestigious peer reviewed journal of Biological Psychiatry.The data from the pivotal clinical trial of vagus nerve stimulation and depression was been on published September 1st, in the prestigious peer-reviewed journal of Biological Psychiatry. Depression-My Story What is depression?Depression is a serious medical illness; it's not something that you have made up in your head. It's more than just feeling "down in the dumps" or "blue" for a few days. Depression Help & Support Groups For those who face depression, every day of their lives may seem like a struggle. A struggle to get up, a struggle to face the day and the people involved and it can be a struggle to make the most of the day. Insurance Reimbursement for Vagus Nerve Stimulation and Depression I attended the Vagus Nerve Stimulation Therapy Conference at the manufacturers' (Cyberonics) headquarters in Houston, TX in late July. The Conference presenters included senior management, psychiatric thought leaders and study investigators from the investigational clinical trial. Depression in Teenagers: Now What Can We Do? No doubt you have seen the recent news headlines about a federal panel that recommended to the FDA that anti-depressant medications carry the strongest possible warning label for use in children and teenagers. This recommendation to the FDA shook the medical community, especially those who work with depressed young people. What About Drugs for Anxiety and Depression? As a counselor, I am often asked, "Can drugs be helpful for anxiety and depression?" The answer I give is "Yes" and "No."Yes, drugs may be useful for short-term help. Antidepressants: Control or Cure? What's curious is that most of them will be on these drugs for life. Equally curious is that over seventy percent of people who stop taking them, for any length of time, will relapse into another painful episode of their illness. Depression in Long Term Care Heart Patients Often Goes Untreated Cardiologists, other doctors and long term carestaff might be missing the big picture as one survey suggeststhat only a third of heart disease patients with serioussymptoms of depression or anxiety get any treatment.The findings are significant because psychological problems havebeen linked to poorer health and higher death rates in heartdisease patients. Depression Explained Depression is a mental state marked by melancholy, pessimism or dejection.Depression can also be defined as a psychotic condition characterized by stuporous withdrawal from reality and intense guilt feelings. Depression The 'experts' have tried to evaluate me as a sufferer of this but found no such evidence or behavior. The same was true for all other mental or medical conditions, so they think 'witch' covers my condition in life; because I refuse to participate in the materially managed environment any more. New Treatment for Depression to be FDA Approved by Late June With the next few weeks, the FDA is expected to issue its final approval of vagus nerve stimulation as a treatment for chronic or recurrent depression. The approval of vagus nerve stimulation will be the first ever FDA approved long-term treatment option for the four million desperate Americans( and their families) who have not had an adequate response to traditional anti-depressants.
|
| home | site map |
| © 2006 |
