October 09, 2009

Shire Trialing ADHD Drug As Add-On Depression Treatment

There has been a flurry of TV ads in Seattle for a research study of an investigational drug plus an anti-depressant for people not getting enough relief from anti-depressants alone. The ads are being run by Summit Research, a clinical trials shop here in Seattle. I thought to myself that there couldn't possibly be another atypical antipsychotic being tested this way (since most are almost off-patent), so I went to poking through clinicaltrials.gov and found that Summit is one of a number of places trialing Shire's Vyvanase, a methamphetamine-based ADHD stimulant, as an add-on treatment for depression in a six-week study expected to be complete next year. It will involve 150 patients and includes a placebo arm so this isn't likely to be an approval trial, but an initial trial to see if a larger trial and FDA approval is worth pursuing.

An ADHD drug as a depression treatment? Sounds pretty dubious to me.

Shire also makes Adderall.

Posted by Philip Dawdy at October 9, 2009 12:05 AM
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Another popular pharmaceutical trial center in Bellevue WA

http://www.al-hakeem.org/links/about_us/khan.htm

Dr. Khan has published over 100 scientific papers. He serves as a reviewer for such journals as The Archives of General Psychiatry, The American Journal of Psychiatry, and Biological Psychiatry. He was extensively involved in research leading to the development of medications such as Prozac, Zoloft, Paxcil, Wellbutrin, Effexor, Serzone, Remeron, Celexa and Buspar. He continues an active research career and presents his work at national and international scientific meetings.

The center is located in Bellevue, Washington.

Another trial in teens

http://clinicaltrials.gov/ct2/show/NCT00531947

Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression

https://www.nwcrc.net/AboutNWCRC/tabid/68/Default.aspx

Since 1995, the Northwest Clinical Research Center has partnered with the pharmaceutical industry to conduct clinical research trials and is dedicated to providing quality medical treatment and patient safety.

Arif Khan, M.D., Medical Director and Principal Investigator at the Center, is a Board Certified Psychiatrist and an Adjunct Professor of Psychiatry at Duke University School of Medicine.

Dr. Khan has published more than 150 scientific papers. He serves as a reviewer for such journals as The Archives of General Psychiatry, The American Journal of Psychiatry, and Biological Psychiatry. He was extensively involved in research leading to the development of medications such as Prozac, Zoloft, Paxil, Wellbutrin, Effexor, Serzone, Remeron, Celexa, Buspar, Zyprexa, Risperdal, Seroquel, Lexapro, Cymbalta, and Abilify. He continues an active research career and presents his work at national and international scientific meetings

http://journals.lww.com/psychopharmacology/Abstract/2008/02000/Aripiprazole_Monotherapy_in_Nonpsychotic_Bipolar_I.3.aspx

Aripiprazole Monotherapy in Nonpsychotic Bipolar I Depression: Results of 2 Randomized, Placebo-Controlled Studies

Thase, Michael E. MD; Jonas, Alan MD; Khan, Arif MD.....

..monotherapy in outpatients with bipolar I disorder experiencing a major depressive episode without psychotic features. Patients were randomized to placebo..

http://clinicaltrials.gov/ct2/show/NCT00110461

tested Abilify for bipolar in children and teens

Responsible Party: Northwest Clinical Research Center ( Arifulla Khan, MD)

They pay you to test the drugs there

Posted by: Stephany at October 9, 2009 12:52 AM

One more

http://www.accessdata.fda.gov/scripts/cder/CLIIL/index.cfm?fuseaction=Browse.Browse&NameFirstLetter=K&StartRow=201&SortField=LastName&SortRequest=0

FDA Clinical Investigator inspection list

Khan's clinic inspected 6 times

Deficiency code inspection results:

02 Failure to obtain and/or document subject consent

03 Inadequate informed consent form

04 Inadequate drug accountability

05 Failure to follow investigational plan

06 Inadequate and inaccurate records

Just sayin'....

Posted by: Stephany at October 9, 2009 01:04 AM

wow. the pharma companies are testing anything for everything, and hoping a significant result pops up.

Posted by: medsvstherapy at October 9, 2009 06:05 AM

Actually this is nothing new -- and it's hardly surprising that speed is an antidepressant, at least in the short term. I believe amphetamines were commonly prescribed for depression back in the twenties and thirties. And you can ask anyone who got hooked on prescription "diet pills" back in the seventies about the effects.

Ten years ago, Adderall itself was popular as an add-on for people not getting relief from antidepressants. Now that it's a fairly cheap generic (and the generic product is labeled "amphetamine salts") nobody wants to hear about that.

I strongly suspect that Vyvanase is either a straight-up Adderall imitator -- a "me-too" drug -- or something mighty close. And that once there's an expensive, patented product, we will see a revival of research on speed as an antidepressant. I expect to be offered this exciting new scientific breakthrough soon. Arrgh.

Posted by: Johanna at October 9, 2009 07:05 AM

I am not surprised. I was diagnosed with depression 18 years ago, but had cyclical bouts and meltdowns despite taking anti-depressants. Three years ago, I headed downhill again, but my new psychotherapist listened more closely than previous ones to me, and suggested ADHD. I underwent a battery of tests, and both the psychologist and a psychiatrist specialized in adult ADHD (my old psychiatrist thought I was bipolar) confirmed my diagnosis. I began treatment with Vyvanse and it turned my life around, resolved a host of personal questions, and set me on a course of finding alternative treatments. I am now discussing with my psychiatrist stopping my anti-depressants. If a person has undetected ADHD, the condition can make him or her miserable, and the standard treatments for depression, anxiety, substance abuse and other co-occurring conditions will do little.

Of course, with Adderall going off patent soon, I have not doubt that Shire is looking to augment its sales volume elsewhere.

Posted by: Michael at October 9, 2009 07:31 AM

As if anti-depressants weren't stimulating enough. Just ask Liz Spikol how great methamphetamine is for depression....

Posted by: Miranda at October 9, 2009 07:49 AM

I have to say, I don't buy into the whole ADD drug for a long-term solution to treatment-resistant depression, but as a short term "jump start," it makes sense to me...and it worked for me. (not sure if the making sense happened before or after that point.)
Had had addition of a stimulant (they suggested ritalin but I ended up using adderall) suggested by an inpatient team at Columbia U hospital as an option if the drug cocktail didn't work out; a few years later having reached the end of my rope we did try it.
I had a six day turn around and all of a sudden understood why people might pursue illegal drugs like amphetamines. I went from acutely suicidal and hospital-bound to...okay.
The shrinks all said it should be short term, as a stimulant for the ADs I was on.....and it was, is, and has been a literal life-saver, for me personally. I didn't enjoy the side effects and didn't want to stay on an amphetamine indefinitely...but I did enjoy being alive and okay with that.

Posted by: michelle at October 9, 2009 08:10 AM

There's some evidence that use of SSRI's causes downregulation of dopamine receptors, and so, it's not as dubious as it may seem.

Of course, there's the risk of stimulant abuse.

Posted by: steve at October 9, 2009 08:34 AM

stimulants have been being used off-label for depression for a long long time. Perhaps not rampantly, but I've seen it many times.

Posted by: mjane at October 9, 2009 09:03 AM

I'd be very careful about jump starting any seriously depressed person. It's too easy to act out the suicide you've been planning if you get some energy before the underlying problem has been resolved. Of course, if ADHD *is* the underlying problem, that's a different matter.

This is all getting so weird to me. I have been annoyed for years whenever I read how "easily treatable" depression is. Oh really? If it's so easily treatable (and I read that often) what's with all this desperate trialing of add ons and adjuncts and new anti-depressants? I realize the profit motive is at work but this kind of kitchen-sink approach would be a lot less plausible if the existing remedies actually WORKED. "Easily treatable," my foot (and other portions of my anatomy).

Posted by: Sherry at October 9, 2009 01:07 PM

My first reaction to this was the danger of adding a stimulant to an antidepressant. Antidepressants are known to cause akathisia and suicidality. Adding a stimulant is like playing with fire. My second concern in this study is that they are excluding those who did not respond favorably to antidepressants. Wouldn't this skew the results?

Posted by: ozjthomas at October 9, 2009 01:22 PM

Stimulants have a long history of use as antidepressants. in fact they were arguably the first antidepressants because amphetamine and cocaine were discovered decades before the first MAOi. Freud recommended cocaine in the treatment of depression, although he was using a lot of it himself at this point and he recanted after a friend got addicted to it.

Posted by: Neuroskeptic at October 11, 2009 09:48 AM

Although having said that, prolonged use of stimulants is one of the best ways of making someone depressed - we've known that for decades as well.

Posted by: Neuroskeptic at October 11, 2009 09:51 AM

I have treated many pts made psychotic by the combination of an SSRI and a stimulant. Very dangerous. Psychiatry has gone off the deep end.

Posted by: John Sorboro MD at October 11, 2009 01:47 PM

Don't you love the evidence base science?
lol
The more they "research" the more evident it is what do they really care for.

I also love the legacy of the "brain decade", do you remember?

"we've known that for decades as well."
Neuroskeptic

Exactly!

And you all we have this knowledge for decades!

To fully understand the brain will take decades. and more decades...

Posted by: Ana at October 11, 2009 02:45 PM

Can anybody tell me what clinical trials are for?

But please explain it seriously.

Posted by: Ana at October 11, 2009 02:46 PM

"An ADHD drug as a depression treatment? Sounds pretty dubious to me."
Philip Dawdy

So we have an arsenal to treat depression: antidepressants, mood stabilizers, anti-psychotics and now ADHD stimulant!

Philip stop raining on healing's parade! You don't want people to get better.

Philip Dawdy's says to himself: Oops! Guess she went crazy.

Posted by: Ana at October 11, 2009 02:51 PM

Forget about stimulants, which do carry the risk of making someone with bad depression go off the deep end into psychosis - especialy if they actually have undiagnosed Bipolar - or leading a person to have akithisia which is really a horrible experience...

I don't see why, if they are willing to rx stimulants short term for serious cases of depression, they don't do the same with opiates.

Have you ever seen someone on opiates (aside from an actual ALLERGIC reaction) become aggitated or psychotic? It doesn't happen - except in the case of allergy. There is no such things as opioid induced psychosis (it's an allergic reaction not an effect of this class of meds), there IS such a thing as stimulant induced psychosis.

You take an opiate and suddenly ALL your pain is gone, emotional and physical, and you are suddenly filled with a sense of safety and wellbeing, as well as a newfound ability to feel pleasure and apreciate the good things going on around you and in your life.

How is that not the complete and total desired outcome of the treatment of depression?

Yes they cause physical tolerance and so must be discontinued slowly and carefuly - but shouldn't ALL psych meds have to be discontinued this way?

Yes they are potentialy addicting medications, but so are stimulants, benzodiazapines (valium etc) and even some antipsychotics and antidepressants... yet we still see these used in psychiatry.

I know people have heard this spiel a million times: "a depressant drug won't help a person with depression"... and so the logic follows that since opiates depress the respiratory system and when ABUSED in high doses lead to sedation, that they can't be good for people who are already depressed. But then doesn't the same logic follow that these "add-on" antispcyhotics that are being advocated for use in depression shouldn't help with depression? Because if there is ANY drug out there that is a real HUGE depressant of ALL the neurotransmitter systems it IS the antipsychotic class of meds.

I can't say it enough times to enough people: Opiates are for some of us the ONLY thing that actually works without causing a hailstorm of side effects. Why psychiatry and research refuse to take seriously the real psychotropic effects of opiates I can not understand, not while they are still willing to look at stimulants which are just as addictive.

Yeah opiates have more physical withdrawal symptoms than many meds used for mental illness, but not more than all the meds out there that are used (effexor can be worse than herion to get off of). Ask Liz Spikol about the physical and mental WDs from "non-addictive" psych meds.

It's going to be an eternaly frustraiting problem for myself and many others that the only class of medications that actually make us feel normal (not high but NORMAL) are for some unclear reason seen as "untouchable" to the psych and research communities. But you know if it works it works and we'll just have to keep doing things without the help of doctors. Sadly because of this there are probably at least tens of thousands of people in the US that end up with an addiction problem from having to self medicate without proper supervision, and who loose control of the use of the only medication that ever helped them - at least for awhile, until having no access to a Dr. who would be willing to help them continue to SAFELY USE The medication and not slip up and end up abusing the medication, ends up leading them down the path of addiction. There are still plenty of us though that are willing to take that risk for the relief we get, and plenty who find a way to keep things from becoming out of hand and successfuly self treat with this class of medications for many years without any ill effect.

It would just be nice to for once be able to go to a psych doctor and say "Opiates help me stay stable, allow me to live a normal life and help me be happy to be alive instead of dreading every day" and have that taken seriously. As it is you are an addict, even if you have no addictive behaviors and have been able to keep it that way for years, if you take opiates for any other reason than pain.

Oh well. Give em all amphetamines and antipsychotics, there's no way that could possibly be as dangerous as those evil opiates that actually make people feel better immediately.
Better to have people on five different half assed medications that still are not relieving thier symptoms than to try one medication that might actually work... ya know, because conventional psych meds are totaly non-addictive and have no withdrawal symptoms or anything... and opiates have a withdrawal syndrome that has been extensively studied and so could be much much better managed than the WD syndromes people get when they decide to try and get of antidepressants and antipsychotics... but yeah, whatever, let's just keep doing things they way we have been doing them, kill more people with more toxic medication combinations, and toss them into the cold blackness of a lack of research and knowledge when they decide to try and come off those medications. It would just be sooooooo horrible to have people taking ONE medication that actually makes them feel 100% better, and then to have an actual effective action plan and tapering schedule to get them off that medication when the time comes that they think they might be able to handle life without it.

From experience I can say it is much easier to self-taper off opiates (even though I am just such a huge addict ya know) following the mountains of published research out there on how to do it, than it has ever been to try and figure out how to safely get off a psych med without being thrown completely off my rocker.

I've tried stimulants to augument my antipsychotic, because I can not take traditional antidepressants ( I become manic, violent and suicidal off SSRI's, SNRI's, TCA's etc) and all it did was make me feel jumpy and gross. But I sort of think sometimes that maybe that is the whole point of taking psych meds, to make you only feel a little bit better, so that there is always room to add another, and another, and another medication.

You can't make money off actually making people feel and be better the first time around.

Posted by: just me at October 17, 2009 01:30 PM

Holy cow, you're making me want to try them :p And I am so not into psychotropics at all.

Posted by: kimbriel at October 17, 2009 03:58 PM
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