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The following is a summary of “Risks of adverse events with mirtazapine for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis,” published in the January 2025 issue of Psychiatry by Kamp et al.
Mirtazapine treats depression with known effects on rating scales, but its impact on adverse events (AEs) needs further study.
Researchers conducted a retrospective study to assess the risks of AEs with mirtazapine in major depressive disorder.
They searched relevant sources from inception to 7 March 2024 for randomized clinical trials comparing mirtazapine versus placebo in adults with major depressive disorder. Primary outcomes included suicides, suicide attempts, and serious and non-serious AEs, with data synthesized using meta-analysis and trial sequential analysis.
The results showed that 17 trials with 2,131 participants were included. All results had a high risk of bias, and evidence certainty was very low. Trials assessed outcomes at a maximum of 12 weeks. Meta-analysis and Trial Sequential Analysis showed insufficient data on suicides, suicide attempts, and serious AEs. Meta-analysis indicated mirtazapine increased risks of somnolence, weight gain, dry mouth, dizziness, and increased appetite but decreased headache risk.
Investigators found insufficient evidence on mirtazapine’s impact on suicides and serious AEs. It increased the risks of somnolence, weight gain, dry mouth, dizziness, and appetite, possibly reducing headaches.
Source: bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06396-6
