Abilify (aripiprazole) is an atypical antipsychotic medication commonly used to treat schizophrenia and acute mania. In 2005, the Food and Drug Administration (FDA) approved its use in the maintenance treatment of bipolar disorder – to prevent the recurrence of mood episodes. Unfortunately, evidence proving the effectiveness of Abilify as a maintenance medication for bipolar disorder is scarce and questionable.

Exposing the Truth

An article published this week in the open access journal PLoS Medicine (Tsai et al) looks critically at the scientific evidence that supports such widespread use of this medicine for maintenance treatment of bipolar disorder. They found only one blind, randomized, controlled trial to support the use of Abilify in the long-term maintenance of bipolar disorder. (A blind, randomized, controlled trial is the type of study considered most valid and useful in scientific research like this.) Furthermore, this trial was sponsored by Bristol Myers Squibb, the pharmaceutical company that markets Abilify in the U.S. The new study raises a number of concerns about the quality of the trial itself:

• The trial was too short to demonstrate maintenance efficacy
• All the trial participants had responded well to aripiprazole as an acute treatment, so the generalizability of the trial’s results was limited
• Some of the apparent beneficial treatment results could have reflected the adverse effects of abrupt medication discontinuation in the control group – in other words, the recurrence of symptoms in those not taking Abilify could have been inflated by people who experienced symptoms due to the abrupt discontinuation of their medications
• The trial had a low completion rate – only one fifth of the original group of patients completed the full 48 weeks of the study

Despite this, the authors of this review in PLoS Medicine found that this one trial was cited 80 times by other authors, and these citations typically suggested that definitive evidence supported the use of Abilify in maintenance treatment. However, few of these citations – only four – mentioned any of the potential flaws in the study or that it was sponsored by the company that markets the medication.

A Travesty for the Medical Profession

This whole story is a travesty for the medical profession – and for psychiatry in particular. We are prescribing a medication in massive numbers with woefully inadequate scientific research to support it:

• There is only one study – you always want to see results replicated in at least one additional study.
• That one study was partly funded by the company that markets the drug – you always want to see at least one independent study (not funded by anyone who stands to make or lose money) that produces similar results.
• The study itself had a number of weaknesses, which is why repeating studies is so important. Every research trial has some potential flaws, and the next study can try to clean those up when it looks at the same question again.

We Can Do Better

Doctors rely on a variety of sources for information to help them in making medication decisions – in this case the power of the data was clearly limited, but the literature presented it as firm science and well supported. Are we lazy? Are we not critical thinkers anymore? Are we just too busy trying to make a living that we don’t have time to do our own careful review of the data? Why aren’t we much, much more skeptical of all studies sponsored by drug makers? Why aren’t we demanding more strong, independent science to help our patients and to reduce the use of unnecessary or inappropriate medication?

I use Abilify in my practice, but extremely cautiously. I think that if we were more aware of how much of the research we rely on is flimsy and drug-company sponsored we would all be far more cautious in our prescribing patterns.

What To Do If You’re Taking Abilify

Abilify may or may not be effective in the maintenance treatment of bipolar disorder. We simply do not have enough reliable evidence to determine whether it is or is not. Abilify has proven effective in treating acute symptoms of bipolar mania. Here’s what you should know:

• Don’t stop taking Abilify if you’re currently taking it.
• If you’re taking Abilify to recover from a serious manic episode, continue taking it. Talk to your doctor about the possibility of tapering Abilify and using an alternative medication for long-term maintenance treatment.
• Discuss with your prescriber the use of other medications that have proven effective in the maintenance treatment of bipolar disorder, including lithium, Depakote, and Lamictal.
• If you are taking Abilify for other indications such as depression or mixed episodes, do not stop taking it, but review with your doctor the reason for choosing this medicine and how you and she will know when to consider coming off of it.

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    Last reviewed: 6 May 2011