TY - JOUR
T1 - The risks of adverse events with mirtazapine for adults with major depressive disorder
T2 - a systematic review with meta-analysis and trial sequential analysis
AU - Kamp, Caroline Barkholt
AU - Petersen, Johanne Juul
AU - Faltermeier, Pascal
AU - Juul, Sophie
AU - Sillassen, Christina Dam Bjerregaard
AU - Siddiqui, Faiza
AU - Andersen, Rebecca Kjaer
AU - Moncrieff, Joanna
AU - Horowitz, Mark Abie
AU - Hengartner, Michael Pascal
AU - Kirsch, Irving
AU - Gluud, Christian
AU - Jakobsen, Janus Christian
N1 - © 2024. The Author(s).
PY - 2025/1/22
Y1 - 2025/1/22
N2 - BACKGROUND: Mirtazapine is used to treat depression worldwide, and the effects of mirtazapine on depression rating scales are well-known. Our primary objective was to assess the risks of adverse events with mirtazapine for major depressive disorder.METHODS: We searched relevant sources from inception to 7 March 2024 for randomised clinical trials comparing mirtazapine versus placebo in adults with major depressive disorder. The primary outcomes were suicides or suicide attempts, serious adverse events, and non-serious adverse events. Data were synthesised using meta-analysis and Trial Sequential Analysis.RESULTS: We included 17 trials randomising 2,131 participants to mirtazapine versus placebo. All results were at high risk of bias, and the certainty of the evidence was very low. The included trials assessed outcomes at a maximum of 12 weeks after randomisation. Meta-analysis and Trial Sequential Analysis showed insufficient information to determine the effects of mirtazapine on the risks of suicides or suicide attempts and serious adverse events. Meta-analyses showed that mirtazapine increased the risks of somnolence, weight gain, dry mouth, dizziness, and increased appetite but decreased the risk of headaches.CONCLUSIONS: There is a lack of evidence on the effects of mirtazapine on suicides and serious adverse events. Mirtazapine increases the risks of somnolence, weight gain, dry mouth, dizziness, and increased appetite. Mirtazapine might decrease the risk of headaches. The long-term effects of mirtazapine are unknown.PROSPERO ID: CRD42022315395.
AB - BACKGROUND: Mirtazapine is used to treat depression worldwide, and the effects of mirtazapine on depression rating scales are well-known. Our primary objective was to assess the risks of adverse events with mirtazapine for major depressive disorder.METHODS: We searched relevant sources from inception to 7 March 2024 for randomised clinical trials comparing mirtazapine versus placebo in adults with major depressive disorder. The primary outcomes were suicides or suicide attempts, serious adverse events, and non-serious adverse events. Data were synthesised using meta-analysis and Trial Sequential Analysis.RESULTS: We included 17 trials randomising 2,131 participants to mirtazapine versus placebo. All results were at high risk of bias, and the certainty of the evidence was very low. The included trials assessed outcomes at a maximum of 12 weeks after randomisation. Meta-analysis and Trial Sequential Analysis showed insufficient information to determine the effects of mirtazapine on the risks of suicides or suicide attempts and serious adverse events. Meta-analyses showed that mirtazapine increased the risks of somnolence, weight gain, dry mouth, dizziness, and increased appetite but decreased the risk of headaches.CONCLUSIONS: There is a lack of evidence on the effects of mirtazapine on suicides and serious adverse events. Mirtazapine increases the risks of somnolence, weight gain, dry mouth, dizziness, and increased appetite. Mirtazapine might decrease the risk of headaches. The long-term effects of mirtazapine are unknown.PROSPERO ID: CRD42022315395.
KW - Mirtazapine/therapeutic use
KW - Humans
KW - Depressive Disorder, Major/drug therapy
KW - Adult
KW - Suicide, Attempted/statistics & numerical data
KW - Randomized Controlled Trials as Topic
KW - Antidepressive Agents, Tricyclic/adverse effects
KW - Suicide/statistics & numerical data
U2 - 10.1186/s12888-024-06396-6
DO - 10.1186/s12888-024-06396-6
M3 - Review
C2 - 39844067
SN - 1471-244X
VL - 25
JO - BMC Psychiatry
JF - BMC Psychiatry
IS - 1
M1 - 67
ER -