For some time, it has been known that the anti-depressant drug Abilify causes people who take it to behave in reckless, impulsive ways. In these situations, manufacturers of such harmful prescription medications argue that the benefits of the product outweigh the risks, often citing self-funded research studies. However, a recent study published in the Journal of the American Medical Association now suggests quite the opposite. Moreover, Abilify may not even be very effective at treating depression at all.
The study followed up a randomized clinical trial of over 1500 subjects – 85% of whom were men. These patients, whose average age was 54, were suffering from major depressive disorder (MDD), a mental illness affecting approximately three million people in the U.S. While the cause of MDD isn’t precisely known, most medical and psychiatric researchers believe that brain chemistry (neurotransmitters) and hormonal changes play a major role.
The original study, carried out at thirty-five Veterans Administration Hospitals between December 2012 and May 2015, followed patients who had been diagnosed with MDD and had been unresponsive to at least one course of treatment. The objective was to find out what happened when patients were either switched to a different medication or given a second one – either Wellbutrin/Zyban (bupropion) or Abilify (aripiprazole), and measure the relative effectiveness of each alternative.
Seventy-five percent of the participants in the study completed the course of treatment. After three months, 22% of patients who were switched to a different medication responded to the new treatment. In comparison 27% of those who were given bupropion in addition to what they were already taking experienced remission of their symptoms, while 29% of patients whose treatment was augmented with Abilify demonstrated a response.
Researchers concluded that the benefits of Abilify among those who completed a 12-week course of treatment was “statistically significant, but only modestly increased the likelihood of remission.” In other words, adding Abilify to an existing regimen might help patients’ depression a little – but not by much.
However, the researchers did note that patients who were given Abilfy experienced excessive sleepiness, weight gain and akathisia (a movement disorder characterized by excessive physical and mental agitation and an inability to stay still for any length of time). The latter is a frequent side effect associated with antidepressants.
In the end, the researchers questioned whether or not Abilify was truly effective as a treatment for depression: “Given the small effect size and adverse effects associated with aripiprazole, further analysis including cost-effectiveness is needed to understand the net utility of this approach.”
Meanwhile, concerns about the behavioral side effects of Abilify continue to grow. Over the past year, more than 200 lawsuits have been filed against drugmakers Otsuka Pharmaceuticals and Bristol-Meyers Squibb. Plaintiffs have found themselves engaging in a range of risky behaviors, including compulsive gambling, shopping and sex, unable to control their impulses while taking the medication.
Despite these known dangers, state departments of juvenile justice have been stockpiling Abilify in order to restrain offenders and inmates. It remains to be seen if the results of this recent study will have any impact on the sales of Abilify, which remains on the list of the top 15 best-selling prescription drugs in the world.