Evidence map›Paper›PMID 39844067›Full record

SynthesisBMC psychiatry2025

The risks of adverse events with mirtazapine for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis.

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 and 3 more

Abstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in BMC psychiatry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Mirtazapine revisited: new therapeutic perspectives and formulation advances.Naunyn-Schmiedeberg's archives of pharmacology · 2026
    Review
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Caroline Barkholt KampCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen Ø, DK-2100, Denmark. caroline.kamp@ctu.dk.
Johanne Juul PetersenCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen Ø, DK-2100, Denmark.
Pascal FaltermeierCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen Ø, DK-2100, Denmark.
Sophie JuulCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen Ø, DK-2100, Denmark.
Christina Dam Bjerregaard SillassenCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen Ø, DK-2100, Denmark.
Faiza SiddiquiCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen Ø, DK-2100, Denmark.
Rebecca Kjaer AndersenCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen Ø, DK-2100, Denmark.
Joanna MoncrieffDivision of Psychiatry (This position is honorary for MAH), University College London, London, W1T 7BN, UK.
Mark Abie HorowitzDivision of Psychiatry (This position is honorary for MAH), University College London, London, W1T 7BN, UK.
Michael Pascal HengartnerDepartment of Applied Psychology, Zurich University of Applied Sciences, Zurich, 8005, Switzerland.
Irving KirschProgram in Placebo Studies, Harvard Medical School, Boston, MA, 02215, USA.
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen Ø, DK-2100, Denmark.
Janus Christian JakobsenCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen Ø, DK-2100, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMirtazapine 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.

methodsWe 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.

resultsWe 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.

conclusionsThere 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.

Indexed as

Antidepressive Agents, TricyclicMajor Depressive DisorderMirtazapineAdultHumansRandomized Controlled Trials as TopicSuicide, AttemptedWeight GainAntidepressive Agents, TricyclicMirtazapineAdverse eventsAntidepressantsMajor depressive disorderMirtazapineSystematic review

Identifiers

PMID39844067
PMCPMC11755810

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.