Saturday, September 24, 2011

St. Jude Medical Receives FDA Approval for Expansion of BROADEN Deep Brain Stimulation Study for Depression

July 11, 2011 St. Jude announced its approval from the FDA to expand the study from 3 hospitals and 30+ people to 20 hospitals and 125 people. Click here for official announcement.   Here is the important (to me) quote:
"pilot study which reported that at six months, 62 percent of the patients experienced at least a 40-percent decrease in symptoms of depression as measured by a standardized test called the Hamilton Rating Scale for Depression. Of these patients, 92 percent maintained this improvement at their last follow-up visit (typically at one year)."
which is similar to the study outcomes of many of the popular anti-depressants on the market today (paxil, zoloft etc).

At the end of the article it re-iterates what I had heard - eventually they want to expand to 231 people.  (See my ramblings in the last paragraph about the odd number 231).

OH - I nearly forgot & had to re-open the post... the announcement sends you to their website to see which site might be nearby.  Um - note to STJ - the map only shows Chicago and Dallas.

A few more implanted people have contacted me.  Almost all of the DBS Depression clinical trials show Active, not recruiting.

One person who knows they are "on" for sure wrote a couple of months ago, just to say hi.  I gave them my disclaimer that I'm thrilled to hear about their experiences but couldn't / wouldn't give them more info about my experience.  They wrote back (and I hope they don't mind me sharing)

"Don't worry about your results hurting my own chances to get better. It's honestly just relieving to know someone out there is getting [some] benefit. I know this is a sloooow process and it isn't a cure-all. But hope is good.

Oh, and this: "I believe the study should provide an LPC for each of us to vent with" - ABSOLUTELY! That would be wonderful."
Again being analytical and making some calculations, I know 10 hospitals were primed and ready to go in July with a waiting list.  At 1 every other week, that would be 5 more per hospital or 50 additional to the "37" (my guess) already implanted.  If we presume the other hospitals were close to being ready, that would mean by the end of next month there should be nearly 125 of us. I AM THRILLED! Move ahead with the study - help 62% more.  (I wish the percentage were higher, but if you consider some experts estimate there are as many as 1.5 million people who don't respond to antidepressants, this will be an option for 900,000 people). [And selfishly, until the FDA approves this, my insurance will not pay for my battery to be replaced!!  Ouch!]

If we consider the other international studies, and the Medtronic studies (which I haven't heard diddly about lately) there may be over 300 of us worldwide. 

Now for some food for thought and entertainment value, watch the movie Limitless.  Consider that one of the working theories on DBS for depression is that it boosts or enhances the effects of drugs in the brain.  Consider Ritalin (and other ADD type meds) boosts or enhances executive functions (thinking).  Consider the class of drugs called Cholinesterase inhibitors which can help memory and learning.  (Cholinesterase inhibitors are alzheimer medicines).  A couple of DBS nodes in the correct area added to drugs enhancing the power of memory & cognition....  The movie calls it NZT.  It won't be long before the ethics boards are screaming.  It won't be long until someone funds the idea of neurological enhancement of IQ with a DBS device. (And you think the use of stem-cells is controversial!!!)

Now I've mentioned I'm kind of analytical, and I've had my share of graduate level statistics classes so the following is nothing more than my rambling out loud about the odd number.  Why 231? Feel free to ignore the following paragraph as me trying to second guess "them".  They started with 3 hospitals and 10 patients apiece, but I suspect some were added and some were dropped.  Rumor has it that 1 was explanted due to side effects and 1 was explanted because they felt they were 'cured'.  (explanted = $64 medical term for "removed device").  Not sure the validity of the rumors, so take it with a HUGE grain of salt.  Officially, the way I understand FDA studies, both of those had to be counted in the statistical analysis of "62% achieved at least a 40% reduction"....  So, if 62% out of 30 achieved a reduction - the math says that would be 18.6 people.  Playing with Excel to try to eliminate a .6 of a person means there are either 34, 37 or 39 of us.  Throwing in the "92% maintained improvement", leads me to believe there are really 37 or 39 or they are just rounding without decimals to be polite.  But back to the odd 231.  Typically in controlled studies, there are 2 groups - those with the real treatment and those without.  Since ultimately we ALL get turned on at some point, the 231 is an enigma.  Often though, controlled studies have multiple groups - like if you were to compare a group taking paxil (SSRI), a group taking wellbutrin (SSNI), a group receiving therapy and a group receiving nothing.  To attempt to control it, one could try to have the same demographic population (about the same ages and having gone through the same background).  Again playing with excel and the number 231, that would mean there could really be 3 groups of 77, 7 groups of 33, 11 groups of 21, 21 groups of 11, 33 groups of 7 or 77 groups of 3.  When there were 3 hospitals doing it, the 3 groups of 77 made sense. But the press release says there are 20 hospitals.  I'm just saying "they" may be studying more than just the efficacy of "gizmo" on us severely depressed.  It could be as simple as patients who have attempted suicide, those who have had a plan for suicide and those who only have thought of suicide.  (Which is much more in-depth than the Hamilton Depression Rating scale suggests).  Food for thought and shows what happens when you THINK too much!  And NOOOO I have no Ritalin nor Alzheimer medicine in my brain right now... yet :)


Anonymous said...

I was wondering if you'd be willing to discuss the screening process for the trial. What kind of questions they ask you, what kind of documentation they require. Please give details. Thanks!
-A patient

C B said...

I am in a different trial for DBS, and to qualify I had to have tried at least four different medications and/or have had ECT therapy. You have to have been severely depressed with no remission for two years. I had to provide the doctors with at least two years of medical records, including any from therapists. I had to do a MADRS (and some other test?) and score at least 30. This test was done by teleconference with someone you have never met before, and knows absolutely nothing about you.

I have a minor heart condition (SVT), asthma, and bad environmental allergies, and I was still able to participate in the trial and did well with the surgery.

Anonymous said...

Just wanted to say that I'm currently trying to get into a dbs trial at Emory U. What hit me closest to the bone were your comments about the pain of depression. I call it the blowtorch. And insidious in that so many of the symptoms work directly against fighting it. So it wins in the survival of the cleverest mental/emotional disorders game. I hope like hell your feeling better. For DBS-I hope for a response, but I'm ready for whatever.
Phil G.

Anonymous said...

With respect to the number 231 -

It is likely that this enrollment/recruitment number was determined by prospective statistical power analysis, based on the responses and impact factors from the pilot (initial) study. At least, that's how we determine numbers for our university's IRB.

Anonymous said...

The number 231 came from 2/3 being turned on 2 weeks after the surgery and the remainder being turned on at 6 months. But "rumor" has it they are discontinuing the study. Anyone want to push St. Jude medical make the official announcement they are pulling out of the study and what is going to happen to those of us in their 4 year follow-up study. I found out info last week and was told it might take them 6-8 weeks or so to go "public" but I heard it on Facebook before from my doctor who said not to tell anyone since they didn't know how to support us yet. But like any full time job they can spend 40 hours a week figuring that out. It shouldn't take them so long. I hope my battery dies before they give up on us. And they did give us a social worker and encouraged us to maintain treatment with our therapist if we had one. That and having supportive therapy and Med changes after 6 months has kept me going. I also want to see their numbers. I feel like I deserve it if they are bailing.

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