A drug used for maintenance treatment of bipolar disorder lacks evidence, scientists contend

Abilify, the brand name of the drug aripiprazole, is an antipsychotic medication used to treat the acute phase of bipolar disorder as well as the maintenance phase -- the period of time after a patient has improved and the focus turns toward preventing a relapse.

This second use of Abilify is the target of a biting review published Tuesday by Dr. Alexander Tsai of Harvard University and Dr. Nicholas Rosenlicht of UC San Francisco. The scientists set out to review data that justify the use of Abilify for the maintenance phase of bipolar disorder -- and found very little.

According to the review, the authors could identify only two studies, both analyses of the same set of data, relevant to their question. The one study, however, is riddled with problems including a limited follow-up period to examine patients in the maintenance phase, an “enriched” sample that might have skewed the results in favor of the drug, possible errors in estimating adverse events and a low rate of participants who actually completed the trial.

This one study, moreover, was funded by the manufacturer of Abilify. According to Tsai and Rosenlicht, they were the only data used by the Food and Drug Administration to support approval of Abilify in the maintenance phase.

Abilify is heavily marketed and, the authors of the analysis say, increasingly used for maintenance -- despite the lack of credible scientific evidence of its value.

“This lack of robust evidence of benefit should be weighed against the potential for long-term harms that have been described with other antipsychotic medications and adverse events related to aripiprazole use, including tremor, akathasia, and significant weight gain,” they wrote.

More studies are needed on the maintenance phase of treatment for people with bipolar, they wrote. As far as the one study that shot Abilify to fame, they said: “We are concerned that the publication and apparently uncritical acceptance of this trial may be diverting patients away from more effective treatments.”

The study was published Tuesday in PLoS Medicine.

Related: Catherine Zeta-Jones is treated for bipolar II disorder. What is it?

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