Banerjee S, High J, Stirling S, et al. - Mirtazapine, an antidepressant prescribed for agitation in dementia, conferred no benefit compared with placebo, and was associated with a potentially higher mortality. Overall, mirtazapine is not supported as a treatment option for agitation in dementia.

• This parallel-group, double-blind, placebo-controlled trial (SYMBAD) included individuals with probable or possible Alzheimer's disease, agitation unresponsive to non-drug treatment, and a Cohen-Mansfield Agitation Inventory (CMAI) score of 45 or more.

• Participants (n= 204) were randomized to receive either mirtazapine (titrated to 45 mg) or placebo.

• At 12 weeks, there was no significant difference in mean CMAI scores between participants receiving mirtazapine vs those receiving placebo (adjusted mean difference –1·74).

• Number of participants with adverse events were similar in both groups (64% in controls vs 66% in the mirtazapine group).

• By week 16, mirtazapine group had more deaths (n=7) vs control group (n=1), with post-hoc analysis indicating this difference was of marginal statistical significance (p=0·065).