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Dr. Bob is Robert Hsiung, MD,
[email protected]Shown: posts 1 to 24 of 24. This is the beginning of the thread.
Posted by djmmm on February 4, 2002, at 13:45:15
Links, etc.
http://www.neurocrine.com/html/clin_anxietyDepression.htm
http://www.lilly.com/about/investor/00report/english/pipeline.html
http://www.frx.com/careers/prodmarkets.shtml
Organon has the following in its pipeline:
5ht1a agonist (ariza) phase 3
5ht2c agonist
dopamine + serotonin + norepinephrine reuptake inhibitor
GRF antagonist
abbot labs has a drug in pre-clinical phase for depression/epilepsy/migraneJuvantia Pharma has an alpha2c adrenergic med in pre-clinical phase
Novartis Pharmaceutical Corporation has a Neurokinin 1 antagonist currently in phase 2
pfizer has a 5-HT1A auto receptor agonist in its pipeline
Lexicon Genetics have developed a LG527 enzyme inhibitor for the treatment of depression... they are in pre-clinical phase (mice lacking this gene show increased activity, etc)
Memory Pharmaceuticals has something for major depression in its pipeline
http://www.memorypharm.com/strategy_pipeline.htmlCyberonics Inc will get FDA approval for VNS (Vagus Nerve Stimulation Therapy) for the treatment of Depression, in June of this year..currently they are in phase 3
Lamictal is in phase 3 for depression
...Im sure there are many more.
Posted by bob on February 4, 2002, at 16:04:49
In reply to New medications, posted by djmmm on February 4, 2002, at 13:45:15
Don't mean to be a wet blanket here, but I have a correction to your info; Cyberonics will not be getting FDA approval for their device this year. They announced disappointing results from their pivotal study where the response was not "statistically different" from placebo. They claim it was entirely due to a flawed study, and not to the device being ineffective. That are planning another pivotal study to prove their point. If this next study is a success, the approval would probably be sometime in 2004 - 2005.
Posted by djmmm on February 4, 2002, at 17:16:50
In reply to Re: New medications » djmmm, posted by bob on February 4, 2002, at 16:04:49
> Don't mean to be a wet blanket here, but I have a correction to your info; Cyberonics will not be getting FDA approval for their device this year. They announced disappointing results from their pivotal study where the response was not "statistically different" from placebo. They claim it was entirely due to a flawed study, and not to the device being ineffective. That are planning another pivotal study to prove their point. If this next study is a success, the approval would probably be sometime in 2004 - 2005.
are you sure? this is from Dec of *2001*
Medical University Of South Carolina Release: Vagus Nerve Stimulation Therapy Continues To Show Long-Term Benefits For Chronic Or Recurrent Depression
CHARLESTON, S.C., Dec. 18 /PRNewswire/ -- New long-term findings demonstrate that patients with difficult to treat chronic or recurrent depression continue to respond to vagus nerve stimulation (VNS) therapy for up to two years. Results from the 60-patient long-term study, led by Mark George, MD, distinguished professor, departments of Psychiatry, Radiology and Neurology at the Medical University of South Carolina, indicate that extended treatment with VNS is associated with the elimination or reduction of depressive symptoms and an improved ability to perform daily functions.
The study, conducted to determine whether the promising results seen in an acute phase (three month) pilot study were sustained after one to two years of treatment with VNS, used remission and response rates as the primary indicators of success. Response means that a patient's depression symptoms were cut in half; remission means that a patient has become virtually symptom-free. The study found that depressed patients with VNS improved over time in terms of remission and response and also improved in their ability to function:
* 27% of patients were in remission after one year, increasing from 15% at the end of the acute study;
* 45% of patients responded to treatment after one year, increasing from 31% at the end of the acute study; and
``There is a need for a more effective and tolerable long-term treatment because 20 to 30 percent of Americans with depression do not respond satisfactorily to currently available treatments,'' stated George. ``The results from this long-term study suggest that VNS could be an effective long-term therapy to help people with chronic and recurrent depression maintain a better quality of life and higher level of day-to-day functioning.''
Depression is a mental illness of global proportions, affecting approximately 340 million people worldwide and more than 18 million American adults. Furthermore, major depression is a leading cause of disability. The illness is characterized by sad moods, loss of interest or pleasure, feelings of guilt or low self-esteem, disturbed sleep and appetite, low energy level and the decreased ability to concentrate. These problems many times become chronic or recurrent and prevent those affected from performing everyday tasks and family and occupational responsibilities.
``Depression is a chronic, disabling lifelong illness that requires a well-tolerated treatment that provides both acute symptom relief and continued benefits,'' stated Harold Sackeim, Ph.D., professor, department of Psychiatry and Radiology, Columbia College of Physicians and Surgeons and New York State Psychiatric Institute. ``Studies of VNS for depression thus far indicate that this therapy may be an option for patients who have not had a positive long-term response to commonly available treatments.''
also, it was approved in canada in April of 2001, and approved in the EU in March of 2001.
Posted by OldSchool on February 4, 2002, at 19:41:39
In reply to New medications, posted by djmmm on February 4, 2002, at 13:45:15
> Cyberonics Inc will get FDA approval for VNS (Vagus Nerve Stimulation Therapy) for the treatment of Depression, in June of this year..currently they are in phase 3
>
>WHOA!!!! Where did you read this at? I didnt think VNS for refractory depression was going to be FDA approved anywhere near this soon. June is only a few months away. Can you tell me where you got this specific information from? Are you sure this is correct? VNS approval in June 2002?
Old School
Posted by OldSchool on February 4, 2002, at 19:52:14
In reply to Re: New medications, posted by djmmm on February 4, 2002, at 17:16:50
>
>
> * 27% of patients were in remission after one year, increasing from 15% at the end of the acute study;This is a low rate of remission compared to bilateral or bifrontal ECT. The remission rates for severe depression with bilateral ECT are around 80%.
>
> * 45% of patients responded to treatment after one year, increasing from 31% at the end of the acute study; andA response is better than nothing, but not good enough. Response and remission are two totally different things. Remission is the goal of depression treatment.
One of the things I like about VNS though is the fact the implant stays in you longterm and the treatment continues daily, for an indefinite period of time. This is the big advantage I can see for VNS over ECT. ECT doesnt last long enough. You have to get the maintenance ECT for long periods to maintain the effect and thats a big pain in the ass. VNS just keeps going and going and from some of the things Ive been reading the response from VNS actually gets better with time. So maybe it will turn out to be a good thing.
However the remission rates published for VNS are not too impressive comparing it to ECT.
Old School
>
Posted by Cmatt on February 5, 2002, at 3:12:56
In reply to Re: New medications, posted by djmmm on February 4, 2002, at 17:16:50
> are you sure? this is from Dec of *2001*
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.
http://www.cyberonics.com/dynamic/PressRelease_detail.asp?ID=240
"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."
A new protocol by June 2002 is mentioned, not FDA approval of the device for treatment of depression.
Cmatt
Posted by Jerrympls on February 5, 2002, at 12:16:14
In reply to Re: New medications, posted by Cmatt on February 5, 2002, at 3:12:56
Interesting. I have a VNS implant as part of the current study and no one mentioned these poor results to me. Hmm
> > are you sure? this is from Dec of *2001*
>
>
>
> 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.
>
> http://www.cyberonics.com/dynamic/PressRelease_detail.asp?ID=240
>
>
> "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."
>
>
> A new protocol by June 2002 is mentioned, not FDA approval of the device for treatment of depression.
>
>
> Cmatt
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
>
>
> > > are you sure? this is from Dec of *2001*
> >
> >
> >
> > 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.
> >
> > http://www.cyberonics.com/dynamic/PressRelease_detail.asp?ID=240
> >
> >
> > "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."
> >
> >
> > A new protocol by June 2002 is mentioned, not FDA approval of the device for treatment of depression.
> >
> >
> > Cmatt
Posted by OldSchool on February 5, 2002, at 21:05:55
In reply to Could you tell us your experience » Jerrympls, posted by Cruz on February 5, 2002, at 14:31:04
> 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?
>
>
>
>The very first VNS implant for purposes of treating refractory depression was done at the Medical University of South Carolina in 1998. Not at Mclean, not at Harvard, not at Yale, not at Duke...but MUSC.
Old School
Posted by bob on February 5, 2002, at 22:48:34
In reply to Re: Could you tell us your experience, posted by OldSchool on February 5, 2002, at 21:05:55
The very first VNS implant for purposes of treating refractory depression was done at the Medical University of South Carolina in 1998. Not at Mclean, not at Harvard, not at Yale, not at Duke...but MUSC.
>
> Old SchoolI'm not sure I understand your point here, Old School.
Posted by Jerrympls on February 6, 2002, at 22:11:45
In reply to Could you tell us your experience » Jerrympls, posted by Cruz on February 5, 2002, at 14:31:04
What I have to say abotu my experiences thus far with the VNS have been interesting to say the least. However, due to strict study protocals I'mnot allowed/strongly disgcouraged from discussing my experiences/results. I will talk to the research doctors and find out when I can let it all out because I am sure many want to know what the scoop is with this implant.
It doesn't suprise me, however - now that I thnk about it--that my settings were too low for too long....but..I cannot be sure.......I promise I will post as soon as it is ok........
Thanks for listening.....
> 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
> >
> >
> > > > are you sure? this is from Dec of *2001*
> > >
> > >
> > >
> > > 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.
> > >
> > > http://www.cyberonics.com/dynamic/PressRelease_detail.asp?ID=240
> > >
> > >
> > > "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."
> > >
> > >
> > > A new protocol by June 2002 is mentioned, not FDA approval of the device for treatment of depression.
> > >
> > >
> > > Cmatt
Posted by Denise528 on February 25, 2002, at 11:50:21
In reply to Re: New medications, posted by Jerrympls on February 5, 2002, at 12:16:14
Jerrympls,
When can you let us know how you are getting on with VNS?
Denise
Posted by Ponder on February 28, 2002, at 14:00:43
In reply to Re: Could you tell us your experience, posted by Jerrympls on February 6, 2002, at 22:11:45
I think Cyberonics is being straight when they say they had a failed study vs. a failed therapy. It is entirely possible that too few people were receiving therapeutic levels of stimulation. Why? They did not want to exceed levels that were comfortable for the patient, so initially many folks were at low settings. As the study progressed, however, they discovered there were other stimulation parameters that could be adjusted to increase the tolerability, allowing the stimulation levels to be comfortably increased. At that point, I think many more participants had their stim. levels moved up to therapeutic levels and began to respond to treatment. Would that be your take on it, Jerry?
Posted by Jerrympls on February 28, 2002, at 18:34:03
In reply to Re: Could you tell us your experience, posted by Ponder on February 28, 2002, at 14:00:43
That's what I have been hearing/reading - almost exactly as you stated below. And as I still can't go into detail - I will say this: For me it hasn't been a cure and at first I was spiraliing downward but then slowly...slowly....slowly.......the sun started to peak out......mind you it's still pretty overcast....but hope is alive and well.
I think I have posted my email address....yes...yes I have. ;-)
> I think Cyberonics is being straight when they say they had a failed study vs. a failed therapy. It is entirely possible that too few people were receiving therapeutic levels of stimulation. Why? They did not want to exceed levels that were comfortable for the patient, so initially many folks were at low settings. As the study progressed, however, they discovered there were other stimulation parameters that could be adjusted to increase the tolerability, allowing the stimulation levels to be comfortably increased. At that point, I think many more participants had their stim. levels moved up to therapeutic levels and began to respond to treatment. Would that be your take on it, Jerry?
Posted by Ponder on March 11, 2002, at 13:38:32
In reply to Re: Could you tell us your experience, posted by Jerrympls on February 28, 2002, at 18:34:03
Jerry, have you found out when you can discuss VNS openly?
Posted by SLS on March 12, 2002, at 18:09:13
In reply to Re: Could you tell us your experience, posted by Jerrympls on February 28, 2002, at 18:34:03
Hi folks.
> That's what I have been hearing/reading - almost exactly as you stated below. And as I still can't go into detail - I will say this: For me it hasn't been a cure and at first I was spiraliing downward but then slowly...slowly....slowly.......the sun started to peak out......mind you it's still pretty overcast....but hope is alive and well.
> > I think Cyberonics is being straight when they say they had a failed study vs. a failed therapy. It is entirely possible that too few people were receiving therapeutic levels of stimulation. Why? They did not want to exceed levels that were comfortable for the patient, so initially many folks were at low settings. As the study progressed, however, they discovered there were other stimulation parameters that could be adjusted to increase the tolerability, allowing the stimulation levels to be comfortably increased. At that point, I think many more participants had their stim. levels moved up to therapeutic levels and began to respond to treatment. Would that be your take on it, Jerry?
A recent study published by Mark George et al. determined that the probability of someone responding well to VNS is low for those who have failed to respond to 7 or more trials of antidepressants. This was confirmed directly by Dr. George to a friend of mine who recently saw him for a consultation. According to her, he quoted a figure of 15% - 20% for the response rate in such cases. Even so, he still recommended to her that she consider VNS as an option.http://www.ndmda.org/ResearchUpdate1-23.html
Although treatment-resistence to medication might indicate a reduced probability of responding to VNS, the same negative association exists for ECT.
Dr. George has also helped to pioneer rTMS (repetitive transcranial magnetic stimulation). The results of the initial clinical trials were disappointing. However, new protocols are being looked at involving higher frequencies and various fluxes (power) and coil placements.
http://www.mhsource.com/pt/p010464.html
I anxiously await Jerry's report of his inevitable positive outcome. (fingers crossed)
- Scott
Posted by Ponder on March 13, 2002, at 23:00:38
In reply to Re: Could you tell us your experience, posted by SLS on March 12, 2002, at 18:09:13
Scott, I hope your friend finds something that works. Sometimes the public awareness campaign claiming that depression is a treatable disease seems cruel. Not so treatable for some of us.
I was in the University of Washington research clinic today and asked what new studies they're doing. Merck's substance P for depression with melancholic features, and Kepra (seizure med) for bipolar. At least the research rolls on, so there is always hope.
Posted by Bob on March 14, 2002, at 1:30:23
In reply to Re: Could you tell us your experience, posted by Ponder on March 13, 2002, at 23:00:38
> Scott, I hope your friend finds something that works. Sometimes the public awareness campaign claiming that depression is a treatable disease seems cruel. Not so treatable for some of us.
I think the same thing every time I see one of those annoying ads for an AD, or whenever some publication tries to inform the public about how treatable depression is. I don't think they're referring to severe depression. To me, severe depression is a whole different ballgame. The problem is, when people hear "treatable", they think, cure. Nobody's thinking when they go for medical treatment for a cure that the treatment won't work, or they will have to go through multiple excruciating trial and error with a possibility of very lackluster results.
Posted by Cecilia on March 14, 2002, at 2:10:30
In reply to Re: Could you tell us your experience » Ponder, posted by Bob on March 14, 2002, at 1:30:23
I agree-I get so mad when I read stuff about depression being so "treatable". I was just reading an article by a psychiatrist opposed to the Oregon assisted suicide law for terminally ill patients, he was saying how these patients wouldn`t want to kill themselves if they weren`t depressed and depression was so treatable etc. I mean what are the odds these patients are going to find the right treatment in the few weeks or months before they die? I think pdocs think depression treatments are a lot more successful than they really are because so many of the unsuccessful patients don`t come back.
Cecilia
Posted by BarbaraCat on March 16, 2002, at 19:00:10
In reply to Re: Could you tell us your experience » Ponder, posted by Bob on March 14, 2002, at 1:30:23
I share your opinions about those dumb ads. Some downtrodden (usually) female pathetic figure drooping by the side of some lake, shoulders hunched over, woe is me look on her haggard face. Then *shazam* enter the magic pill - doesn't matter which pill, cause depression is treatable, right? Then cut to a lively community oriented righteous 40-ish babe doing the Makarena with a yowza gleam in her post depressed eye.
Yeah, right. I think we all know better, but at least it gets folks who think there is no chance in hell to at least step onto the medication merry-go round and dance (the Apoc-calypso?) with some of us other frequent flyer sufferers.
Posted by Bob on March 17, 2002, at 0:46:15
In reply to Fooey on those dippy ads » Bob, posted by BarbaraCat on March 16, 2002, at 19:00:10
> Yeah, right. I think we all know better, but at least it gets folks who think there is no chance in hell to at least step onto the medication merry-go round and dance (the Apoc-calypso?) with some of us other frequent flyer sufferers.--------------------------------------------------
When you say "we all know better", are you referring to us here on PB? That I would agree with. I certainly don't think the unwashed masses know better. I think the general thought of someone who has never taken a psychiatric drug when they see one of those commercials is that the drugs will make you truly happy sans annoying, unrelenting side effects. Those commercials are there to make money. They are not an altruistic outreach program for people in pain. If that were the case, you'd be seeing the ads done by nonprofit orgs.
Posted by BarbaraCat on March 17, 2002, at 13:22:58
In reply to Re: Fooey on those dippy ads » BarbaraCat, posted by Bob on March 17, 2002, at 0:46:15
Yes, of course I'm referring to us here on this board as 'in the know', or anyone for that matter who has allowed great hope that we could be 'cured' as easily as taking a pill, and then had our hopes dashed. Also, remember Peter Kramer's 'Listening to Prozac' book that extolled the virtues of taking a pill to feel better than good? I happen to know a few people who took one course of prozac, zoloft, whatever, and it worked wonders for them. Then they went off and stayed well. I think their biochemistry is very different than mine or yours or anyone's that posts regularly to this board. I'm not sure what that difference is, but it makes me wonder if what we have will ever be cured by a pill. It makes me wonder if starting to take those pills was a bad idea in that now I doubt I can ever come off of them, even though I'm not near feeling 'cured'.
Posted by Bob on March 17, 2002, at 13:27:04
In reply to Re: Fooey on those dippy ads » Bob, posted by BarbaraCat on March 17, 2002, at 13:22:58
> Yes, of course I'm referring to us here on this board as 'in the know', or anyone for that matter who has allowed great hope that we could be 'cured' as easily as taking a pill, and then had our hopes dashed. Also, remember Peter Kramer's 'Listening to Prozac' book that extolled the virtues of taking a pill to feel better than good? I happen to know a few people who took one course of prozac, zoloft, whatever, and it worked wonders for them. Then they went off and stayed well. I think their biochemistry is very different than mine or yours or anyone's that posts regularly to this board. I'm not sure what that difference is, but it makes me wonder if what we have will ever be cured by a pill. It makes me wonder if starting to take those pills was a bad idea in that now I doubt I can ever come off of them, even though I'm not near feeling 'cured'.
--------------------------------------------------
My thoughts exactly!
Posted by Jerrympls on March 23, 2002, at 2:14:28
In reply to Discussing VNS, posted by Ponder on March 11, 2002, at 13:38:32
> Jerry, have you found out when you can discuss VNS openly?
No. But I have heard through the grapevine that the beginning of May I should be able to spill the beans. Trust me, when I can, I will give a full report on my complete experience - good, and bad and...........to be continued....I have my monthly VNS appt. next Fri. I'll ask my Dr. then.
Thanks
Jerry
This is the end of the thread.
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