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 :)