Tuesday, June 09, 2009

Abilify for Depression: Patients Give it an Oh-For-Three

Abilify for depression: you've seen the ads. You've hopefully read this blog (1, 2) and the excellent series in the LA Times from Melissa Healy. The advantage over placebo is nothing to get particularly excited about. Especially from the patients' point of view. As I have mentioned previously, the two studies that were touted by key opinion leaders are supporting the efficacy of Abilify for depression suffered from a number of problems. Most germane to this post, the patient self-report rating scales did not indicate a significant advantage for Abilify in either study.

Well, yet another Abilify for depression study is out in CNS Spectrums and guess what... Still not a significant advantage over placebo according to patients. So in each of three large studies, Abilify has failed to beat a placebo according to patients' self-report. These three trials are the basis for the massive marketing campaign and an FDA approval. Abilify started off as an also-ran antipsychotic. But times have changed. Bristol-Myers Squibb's CEO prophetically stated in 2004 after Abilify's approval as a treatment for bipolar disorder:
This approval underscores our commitment to delivering innovative solutions that address unmet needs for a broad spectrum of patients with mental illness, as well as their families and health care providers.
He could as easily have stated: "This approval underscores our commitment to rebranding our unpopular antipsychotic as a Swiss Army Knife/broad spectrum psychotropic that treats everything under the sun. If I can get the FDA and the public to believe that this akathisia-inducing bottom feeder can treat depression, then I'll be LOADED, BWAAH, HA HA HA HA!!!"

OK, maybe he didn't actually say any of those things, but his "broad spectrum" comment was literally right on the money. Just don't ask those pesky patients what they think; they might tell you it's no better than a damn sugar pill.

Yes, I'm aware that on some other rating scales, Abilify was rated as superior to a placebo, but I'm thinking that if the patient self-report of depression is consistently not favorable for Abilify, then who are we kidding by calling it an antidepressant?

ResearchBlogging.org

Robert M. Berman, Maurizio Fava, Michael E. Thase, Madhukar H. Trivedi, René Swanink, Robert D. McQuade, William H. Carson, David Adson, Leslie Taylor, James Hazel, & Ronald N. Marcus (2009). Aripiprazole Augmentation in Major Depressive Disorder: A Double-Blind, Placebo-Controlled Study in Patients with Inadequate Response to Antidepressants CNS Spectrums, 14 (4), 197-206

3 comments:

Anonymous said...

Abilify is one of the worst drugs out on the market today. On 2.5 milligrams for 5 days, I became shaky,extremely depressed,was unable to concentrate or recall certain words. Zombie? No. Feel like I am in hell? Yes. And this is four days after I discontinued this horrible drug.

Anonymous said...

My son started taking 2mg of Abilify. Now he is on 5mg. He is a completely different child (for the best.) He was everyday in trouble at school. No respect to his teachers and peers. Always calling out names. Calling himself stupid. Had no friends. At home was as bad as it was in school. He always talked back to me. Yelled and screamed when he didn't get his way. Today he gets only daily great reviews from his teachers. He has friends. He plays soccer and all his team likes him. He respect other people. Abilify is a miracle pill to me.

Anonymous said...

Read more on rebranding Abilify, here:

http://tinyurl.com/yhz5cve