Study of Mirtazapine for Agitated Behavior in Dementia (SYMBAD): A Randomized, Double-Blind, Placebo-Controlled Trial

Open Access Publication date: October 23, 2021 DOI: https : //doi.org/10.1016/S0140-6736(21)01210-1

Commentary

The phenomenon of agitation is common in people with dementia and negatively impacts the quality of life for both the person with dementia and their caregivers.

Non-pharmacological treatment is the first choice, but if this treatment is not effective, other treatments may be needed.

Current evidence is sparse on safer and more effective alternatives to antipsychotics.

In this study, we evaluated the efficacy and safety of mirtazapine, an antidepressant prescribed for the excitement of dementia.

The parallel-group, double-blind, placebo-controlled study was conducted at 26 centers in the United Kingdom.

Participants had a likelihood or probability of Alzheimer's disease, excitability unresponsive to non-drug treatment, and a Cohen-Mansfield Excitation Inventory (CMAI) score of 45 or higher.

Between January 26, 2017 and March 6, 2020, 204 participants were recruited and randomized.

Results showed that the mean CMAI score at 12 weeks was not significantly different between participants who received mirtazapine and those who received placebo. The number of controls with adverse events (65 [64%] of 102 controls) was similar to the number in the mirtazapine group (67 [66%] of 102 participants who received mirtazapine).

However, there were more deaths by week 16 in the mirtazapine group (n = 7) than in the control group (n = 1), and post-hoc analysis suggested that this difference was of marginal statistical significance (p = 0.065).