This parallel-group, double- blind, ransomised, placebo-controlled trial conducted in 26 United Kingdom centres, investigated the efficacy and tolerability of mirtazapine versus placebo in treating agitation in patients with probable or possible Alzheimer’s disease. The results of this study showed that the levels of agitation measured at 12 weeks of patients receiving mirtazapine were not significantly different from those of patients receiving placebo. Moreover, there were some indications of a potentially higher mortality in the mirtazapine group. The authors concluded that mirtazapine is not recommended as a treatment for agitation in dementia.
Banerjee S, High J, Stirling S, et al. Study of mirtazapine for agitated behaviors in dementia (SYMBAD): a randomised, double-blind, placebo-controlled trial. Lancet. 2021 Oct 23;398(10310):1487-1497 doi: https://doi.org/10.1016/S0140-6736(21)01210-1.