Posted by Cruz on February 5, 2002, at 14:31:04
In reply to Re: New medications, posted by Jerrympls on February 5, 2002, at 12:16:14
It would be interesting to hear how you are doing with this treatment. Could you also describe your depression symptoms. Is a certain type of depression more likely to be helped with VNS?
> Interesting. I have a VNS implant as part of the current study and no one mentioned these poor results to me. Hmm
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> > > are you sure? this is from Dec of *2001*
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> > Here is quote taken from a January 22,2002 press release from the www.Cyberonics.com web site with the link to the press release below.
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> > http://www.cyberonics.com/dynamic/PressRelease_detail.asp?ID=240
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> > "Dr. Rudolph added, “Although we are disappointed in the acute study results, it is noteworthy that approximately 50% of clinical trials submitted in recent antidepressant New Drug Applications were failed trials. Our preliminary review suggests that the lack of a significant difference between treatment and placebo groups represents a failed study, not a failure of the therapy. We remain confident in the unique value of VNS Therapy as a treatment for depression. Although our depression PMA-S submission may be delayed for two or three years, when it is submitted, it will be supported by compelling long-term clinical evidence that VNS Therapy is an effective and tolerable long-term maintenance therapy which could benefit up to 4 million people with chronic or recurrent depression. The need is still there and the VNS Therapy investigators and patients are still enthusiastic. We expect that we will have FDA approval for our new protocol by June 2002."
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> > A new protocol by June 2002 is mentioned, not FDA approval of the device for treatment of depression.
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> > Cmatt
poster:Cruz
thread:92834
URL: http://www.dr-bob.org/babble/20020131/msgs/92974.html