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clinical psychology and psychiatry a closer look agitating research skip to main skip to sidebar clinical psychology and psychiatry a closer look psychiatric medications science marketing psychiatry in general and occasionally clinical psychology questioning the role of key opinion leaders and the use of science to promote commercial ends rather than the needs of people with mental health concerns wednesday december 13 2006 agitating research aripiprazole abilify is now available in injectable form and is allegedly a great way to calm down patients quickly here s a piece from the press release touting the release of this medication abilify injection provides rapid control of agitation in adults with schizophrenia or bipolar mania at primary endpoint 2 hours let s see if the numbers actually support this statement from one abstract andrezina et al 2006 at 2 h mean improvements in pec scores with im aripiprazole 8 0 were significantly greater versus im placebo 5 7 p less than or 0 01 that is a difference of 2 3 points the abilify group changed by 29 more than the placebo from another abstract also andrezina et al 2006 in a slightly different study mean improvement in pec at 2 h was significantly greater for im aripiprazole 7 27 vs placebo 4 78 p less than 0 001 a difference of 2 49 points the abilify group changed 34 more than placebo what is the pec you might wonder it s the positive and negative syndrome scale excited component and i m willing to venture a guess that a difference of less than three points versus placebo is not particularly compelling clinical evidence it has five questions each of which is scored on a 7 point scale but wait there s more the first study i mentioned was a sub population analysis of 325 patients with agitation i m betting that the second study was just the first study with a few more patients thrown in whose initial scores on the pec were not as high as in the second study looking at the abstracts quickly one might think they were entirely different studies but i highly doubt this is the case i ll do more research and correct myself if i am wrong although if an enlightened reader has this information readily available please let me know so coming back to efficacy we have a large sample size which helps make this apparently small difference between drug and placebo turn up as statistically significant way too many people are under the impression that statistical significance is the most important thing since sliced bread all it shows in this case is that there really is a difference between abilify and placebo but it does not say if the difference was teeny tiny or if it was gigantic to put this in perspective remember that the panss ec is a 35 point scale so a difference of 2 3 points is nothing to write home about don t worry as is highly common in pharmaceutical press releases discussing research an academic spokesperson chimed in abilify injection controls agitation independent of sedation according to michael h allen md director emergency psychiatry associate professor university of colorado at denver and health sciences center s school of medicine what is not mentioned in the press release is that dr allen is a member of the scientific advisory board has received research support from and is a member of the speakers bureau for you guessed it bristol myers squibb distributor of abilify it is always helpful to place a little academic credibility onto your press release dr allen has relationships with several other pharmaceutical companies as well and his opinion on abilify may indeed be separate from his financial relationship with bms it is however certainly misleading for the press release to not mention that dr allen has a significant relationship with the company making him appear as if he were only an independent academic researcher thus the question for today is as follows does abilify reduce agitation to a meaningful degree more than placebo or does this marketing campaign make you significantly agitated posted by cl psych at 12 13 2006 06 44 00 am 2 comments kass said i d like to know the difference between abilify in pill form vs injectable form friday december 15 2006 10 54 00 am cl psych said injectable lasts longer and also should allow for better compliance at least in the short term since the dose is spread across a longer time frame than oral i ve not seen much research that actually finds injectable meds to have better results than oral but their main marketing points are a quick onset of action and better compliance i believe that abilify is currently recommended to only be used in injectable form for the short term then switching to oral friday december 15 2006 11 17 00 am post a comment newer post older post home subscribe to post comments atom email email me blog archive 2011 1 february 1 2010 8 october 1 may 1 april 1 march 3 february 1 january 1 2009 33 december 1 october 1 september 2 august 1 july 4 june 4 may 2 april 5 march 5 february 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to get us man authorship again sunderland admits guilt new york says no to vns email problems the bad psychiatrist blog sexual side effects of ssris even more troubling peter rost wow iloperidone saves the day congrats to kazdin good reader comment a good week for atypical antipsychotics go blackwell more on lexapro vs cymbalta cymbalta and zyprexa good news a silver bullet lexapro beats cymbalta this is depressing more conflicts of interest advocating for patients and or drugs effects the size of bolders meet the last psychiatrist try this on for sleazy seroquel is great drug safety monitoring anyone gsk commence phiring well duh alpha 2 agonists for ptsd nope therapeutic relationship and bipolar disorder outc is it really depression the end is near paxil in pregnancy cost benefits of new schizophrenia drugs doubted november 69 october 48 september 43 academia bitch ph d crooked timber inside higher ed pharma general brandweeknrx edrugsearch gooznews health care renewal jim edwards 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