An antidepressant commonly used to address agitation in long-term care residents with dementia does not work any better than a placebo, a new study finds.
Investigators from the University of Plymouth, in the U.K., assigned 204 patients with probable or possible Alzheimer’s disease to receive 45 mg of the drug, mirtazapine, or placebo. Agitation levels were measured using the standard Cohen-Mansfield Agitation Inventory (CMAI) score.
At 12 weeks, patients’ mean CMAI scores were not significantly different whether they had received mirtazapine or the placebo, the researchers reported. The number of controls who experienced adverse events (64%) was similar to that in the mirtazapine group (66%). What’s more, patients who took the drug had potentially higher odds of death, they noted.
The results show that normal clinical use of mirtazapine is not effective for addressing clinically significant agitation in people with dementia, Naji Tabet, M.D., University of Sussex, Brighton, U.K., wrote. The results have important implications for practice, he said.
“This study shows that a common way of managing symptoms is not helpful—and could even be detrimental,” said lead author Sube Banerjee, M.D., in a statement. “It’s really important that these results are taken into account and mirtazapine is no longer used to treat agitation in people with dementia.”
The randomised, double-blind, placebo-controlled study was published in the Lancet.
