NOVEMBER 6, 2008

ABILIFY ME TO HELP ME FIND THE USEFULNESS OF THIS DRUG FOR DEPRESSION

Bristol Myers Squibb (BMS) recently started a TV ad for their drug Abilify (aripiprazole) which has gotten a lot of people in a tizzy prompting me to look closer at this new claim for a psychiatric drug. First of all, I previously gave honorable mention to Abilify as one of the medications with the goofiest names "Where Do They Come Up with those Goofy Names for Prescription Medications Anyway?")

Abilify Me Please















Back then I mused that perhaps the manufacturers thought that their anti-psychotic pill would make non-functional mental patients jump out of their chairs and start climbing the corporate ladder. Well I don't know if it will make you climb the corporate ladder, but the akathisia you could get might make you feel like you wanted to jump out of a chair. Not to mention wanting to jump up and go pee if you develop second generation antipsychotic induced diabetes. This medication is an antipsychotic (apparently not mentioned in the TV ads) and these drugs can can have some nasty side effects.

So is this drug really useful for depression? The ads hype the fact that over half of people may not respond to antidepressant medications, but that seems like a self serving turnaround on the part of the drug companies (including BMS maker of Serzone (nefazodone)) who have been telling us for years that their antidepressant drugs are magic bullets for depression.

So what do the studies actually show?

In the first study of Abilify, 362 patients were randomly assigned to Abilify or placebo for six weeks after a failed trial of antidepressants. There was a -8.8 v -5.8 change on the Montgomery Asberg Depression Rating Scale (MADRS), a difference of 11.5%. 23% of patients on Abilify versus 5% on placebo had akathisia, a potentially very disturbing side effect where you feel like you are jumping out of your skin or cannot sit still. Restlessness was seen in 14% v 3%. Fatigue was also more common. Berman RM et al J Clin Psychiatry 2007; 68: 843-53.

In the second study of Abilify, 381 patients who had failed at least one antidepressant medication trial were treated for eight weeks with an antidepressant followed by the addition of Abilify or a placebo for six weeks. Abilify showed an -8.5 change on the 26 item Montgomery Asberg Depression Rating Scale (MADRS) versus -5.7 for placebo, a difference of 2.8 points, a difference of 11%. 26% of patients on Abilify versus 4% on placebo had akathisia, and 10% versus 1% had restlessness. Marcus RN et al, J Clin Psychopharm 2008; 28(2):156-165

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Conclusions? Abilify is more likely to make you want to jump out of your skin than it is to cure your depression. An 11% improvement over placebo is not that great and is set off by the fact that Abilify has a lot of nasty side effects and doesn't work better than other treatments of refractory depression like lithium (which also can have nasty side effects). I don't watch TV ads because I have TiVo but I can only imagine how it was presented by BMS

That settled, now we can move on to my favorite study that I found in the literature: Egashira N et al, Aripiprazole inhibits marble-burying behavior via 5-hydroxytryptamine (5-HT)1A receptor-independent mechanisms. European Journal of Pharmacology. 592(1-3):103-8, 2008 Sep 11.

Searching for my marbles






I wonder if the September 11 publication date is a coincidence? OK, conspiracy theory time now. Maybe BMS is trying to tell us that if our government officials had been on Abilify they wouldn't have lost their marbles and allowed 9/11 to become a reality?

Any other theories?

[disclosures: In addition to consulting to competing drug companies listed in my "disclosures" link I have also co-authored papers both with some of the authors of the Abilify studies as well as physicians who have given CME activities that endorsed the use of Abilify for the treatment of depression.]

To comment on this blog please write to jamesdouglasbremner@yahoo.com and indicate whether comments are public or private. If you click on the comment link your comments will get truncated after a couple of sentences (sorry).

Anonymous Reader wrote on November 7 2008

Doug

I think you've gone too far this time. For years, I've been trying to find a way to stop my mice from burying their marbles without affecting their locomotor activity, and now we finally have an effective agent, thanks to the creative genuises at Kyushu University and Otsuka Pharmceuticals. At least our taxpower money didn't go into this one!

Doug Bremner wrote on November 7 2008

Anonymous, just writing in jest. I have nothing against research on marbles, just thought the study title sounded funny. Cheers.

This post was discussed by Philip Dawdy at Furious Seasons with an active discussion there.

Therapy Patient wrote on November 12 2008

I couldn't link to the marble-burying article because it required a password, but if marble-burying represents anxiety (in a lab animal?) then I'd agree (though I enjoyed your humorous interpretation more). My interpretation of what I feel when I take Abilify (1 pill of 5mg dose after not having been on the medication for many months) is a dramatic reduction in anxiety in 20-30 minutes, so I imagine if I buried marbles when anxious that I'd stop.

Not counting the many things I experienced which were possible side-effects, the effect I disliked the most about Abilify was the way it took away my feelings. Gone. I did not feel happy or sad. I lost my sense of humor and effectively became a robot. I typically am not depressed though, so am not in the same situation as the study subjects. A positive effect was that oddly, I lost all tendencies to procrastinate, focused on the most important thing first and got large quantities of work done. It's not a fair trade off for me, though.

Doug Bremner wrote on November 12 2008

Welcome, therapy patient. I have no idea what marble burying is supposed to represent. I just thought it sounded funny. Personally I lost my marbles years ago and haven't been able to find them since.

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