The risks of adverse events with mirtazapine for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis
Abstract 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...
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BMC
2025-01-01
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| Online Access: | https://doi.org/10.1186/s12888-024-06396-6 |
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| author | Caroline Barkholt Kamp Johanne Juul Petersen Pascal Faltermeier Sophie Juul Christina Dam Bjerregaard Sillassen Faiza Siddiqui Rebecca Kjaer Andersen Joanna Moncrieff Mark Abie Horowitz Michael Pascal Hengartner Irving Kirsch Christian Gluud Janus Christian Jakobsen |
| author_facet | Caroline Barkholt Kamp Johanne Juul Petersen Pascal Faltermeier Sophie Juul Christina Dam Bjerregaard Sillassen Faiza Siddiqui Rebecca Kjaer Andersen Joanna Moncrieff Mark Abie Horowitz Michael Pascal Hengartner Irving Kirsch Christian Gluud Janus Christian Jakobsen |
| author_sort | Caroline Barkholt Kamp |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-7060e735e1064c4e952950a32528c975 |
| institution | Kabale University |
| issn | 1471-244X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychiatry |
| spelling | doaj-art-7060e735e1064c4e952950a32528c9752025-01-26T12:46:45ZengBMCBMC Psychiatry1471-244X2025-01-0125111110.1186/s12888-024-06396-6The risks of adverse events with mirtazapine for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysisCaroline Barkholt Kamp0Johanne Juul Petersen1Pascal Faltermeier2Sophie Juul3Christina Dam Bjerregaard Sillassen4Faiza Siddiqui5Rebecca Kjaer Andersen6Joanna Moncrieff7Mark Abie Horowitz8Michael Pascal Hengartner9Irving Kirsch10Christian Gluud11Janus Christian Jakobsen12Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital – RigshospitaletCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital – RigshospitaletCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital – RigshospitaletCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital – RigshospitaletCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital – RigshospitaletCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital – RigshospitaletCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital – RigshospitaletDivision of Psychiatry (This position is honorary for MAH), University College LondonDivision of Psychiatry (This position is honorary for MAH), University College LondonDepartment of Applied Psychology, Zurich University of Applied SciencesProgram in Placebo Studies, Harvard Medical SchoolCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital – RigshospitaletCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital – RigshospitaletAbstract 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.https://doi.org/10.1186/s12888-024-06396-6AntidepressantsMirtazapineMajor depressive disorderAdverse eventsSystematic review |
| spellingShingle | Caroline Barkholt Kamp Johanne Juul Petersen Pascal Faltermeier Sophie Juul Christina Dam Bjerregaard Sillassen Faiza Siddiqui Rebecca Kjaer Andersen Joanna Moncrieff Mark Abie Horowitz Michael Pascal Hengartner Irving Kirsch Christian Gluud Janus Christian Jakobsen The risks of adverse events with mirtazapine for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis BMC Psychiatry Antidepressants Mirtazapine Major depressive disorder Adverse events Systematic review |
| title | The risks of adverse events with mirtazapine for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis |
| title_full | The risks of adverse events with mirtazapine for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis |
| title_fullStr | The risks of adverse events with mirtazapine for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis |
| title_full_unstemmed | The risks of adverse events with mirtazapine for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis |
| title_short | The risks of adverse events with mirtazapine for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis |
| title_sort | risks of adverse events with mirtazapine for adults with major depressive disorder a systematic review with meta analysis and trial sequential analysis |
| topic | Antidepressants Mirtazapine Major depressive disorder Adverse events Systematic review |
| url | https://doi.org/10.1186/s12888-024-06396-6 |
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