The risks of adverse events with venlafaxine and mirtazapine versus 'active placebo', placebo, or no intervention for adults with major depressive disorder: a protocol for two separate systematic reviews with meta-analysis and Trial Sequential Analysis.
Adverse effects
Adverse events
Antidepressants
Beneficial effects
Major depressive disorder
Mirtazapine
Venlafaxine
Journal
Systematic reviews
ISSN: 2046-4053
Titre abrégé: Syst Rev
Pays: England
ID NLM: 101580575
Informations de publication
Date de publication:
30 03 2023
30 03 2023
Historique:
received:
08
03
2022
accepted:
17
03
2023
medline:
31
3
2023
entrez:
29
3
2023
pubmed:
30
3
2023
Statut:
epublish
Résumé
Major depressive disorder causes a great burden on patients and societies. Venlafaxine and mirtazapine are commonly prescribed as second-line treatment for patients with major depressive disorder worldwide. Previous systematic reviews have concluded that venlafaxine and mirtazapine reduce depressive symptoms, but the effects seem small and may not be important to the average patient. Moreover, previous reviews have not systematically assessed the occurrence of adverse events. Therefore, we aim to investigate the risks of adverse events with venlafaxine or mirtazapine versus 'active placebo', placebo, or no intervention for adults with major depressive disorder in two separate systematic reviews. This is a protocol for two systematic reviews with meta-analysis and Trial Sequential Analysis. The assessments of the effects of venlafaxine or mirtazapine will be reported in two separate reviews. The protocol is reported as recommended by Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols, risk of bias will be assessed with the Cochrane risk-of-bias tool version 2, clinical significance will be assessed using our eight-step procedure, and the certainty of the evidence will be assessed with the Grading of Recommendations Assessment, Development and Evaluation approach. We will search for published and unpublished trials in major medical databases and trial registers. Two review authors will independently screen the results from the literature searches, extract data, and assess risk of bias. We will include published or unpublished randomised clinical trial comparing venlafaxine or mirtazapine with 'active placebo', placebo, or no intervention for adults with major depressive disorder. The primary outcomes will be suicides or suicide attempts, serious adverse events, and non-serious adverse events. Exploratory outcomes will include depressive symptoms, quality of life, and individual adverse events. If feasible, we will assess the intervention effects using random-effects and fixed-effect meta-analyses. Venlafaxine and mirtazapine are frequently used as second-line treatment of major depressive disorder worldwide. There is a need for a thorough systematic review to provide the necessary background for weighing the benefits against the harms. This review will ultimately inform best practice in the treatment of major depressive disorder. PROSPERO CRD42022315395.
Sections du résumé
BACKGROUND
Major depressive disorder causes a great burden on patients and societies. Venlafaxine and mirtazapine are commonly prescribed as second-line treatment for patients with major depressive disorder worldwide. Previous systematic reviews have concluded that venlafaxine and mirtazapine reduce depressive symptoms, but the effects seem small and may not be important to the average patient. Moreover, previous reviews have not systematically assessed the occurrence of adverse events. Therefore, we aim to investigate the risks of adverse events with venlafaxine or mirtazapine versus 'active placebo', placebo, or no intervention for adults with major depressive disorder in two separate systematic reviews.
METHODS
This is a protocol for two systematic reviews with meta-analysis and Trial Sequential Analysis. The assessments of the effects of venlafaxine or mirtazapine will be reported in two separate reviews. The protocol is reported as recommended by Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols, risk of bias will be assessed with the Cochrane risk-of-bias tool version 2, clinical significance will be assessed using our eight-step procedure, and the certainty of the evidence will be assessed with the Grading of Recommendations Assessment, Development and Evaluation approach. We will search for published and unpublished trials in major medical databases and trial registers. Two review authors will independently screen the results from the literature searches, extract data, and assess risk of bias. We will include published or unpublished randomised clinical trial comparing venlafaxine or mirtazapine with 'active placebo', placebo, or no intervention for adults with major depressive disorder. The primary outcomes will be suicides or suicide attempts, serious adverse events, and non-serious adverse events. Exploratory outcomes will include depressive symptoms, quality of life, and individual adverse events. If feasible, we will assess the intervention effects using random-effects and fixed-effect meta-analyses.
DISCUSSION
Venlafaxine and mirtazapine are frequently used as second-line treatment of major depressive disorder worldwide. There is a need for a thorough systematic review to provide the necessary background for weighing the benefits against the harms. This review will ultimately inform best practice in the treatment of major depressive disorder.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42022315395.
Identifiants
pubmed: 36991504
doi: 10.1186/s13643-023-02221-5
pii: 10.1186/s13643-023-02221-5
pmc: PMC10061867
doi:
Substances chimiques
Mirtazapine
A051Q2099Q
Venlafaxine Hydrochloride
7D7RX5A8MO
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
57Informations de copyright
© 2023. The Author(s).
Références
Stat Med. 2002 Jun 15;21(11):1539-58
pubmed: 12111919
J Clin Epidemiol. 2008 Jan;61(1):64-75
pubmed: 18083463
Stat Med. 1987 Apr-May;6(3):341-50
pubmed: 3616287
BMJ. 2015 Jan 02;350:g7647
pubmed: 25555855
Cochrane Database Syst Rev. 2004;(1):CD003012
pubmed: 14974002
J Clin Epidemiol. 2011 Apr;64(4):380-2
pubmed: 21185693
Pharmacogenomics. 2019 Jul;20(11):829-845
pubmed: 31368838
BMC Med Res Methodol. 2014 Feb 18;14:25
pubmed: 24548571
Arch Gen Psychiatry. 1999 Jul;56(7):617-26
pubmed: 10401507
Int J Epidemiol. 2009 Feb;38(1):287-98
pubmed: 18824466
Syst Rev. 2021 May 25;10(1):154
pubmed: 34034811
J Manag Care Pharm. 2007 Jul;13(6 Suppl A):S8-18
pubmed: 17874482
BMC Med Res Methodol. 2010 Oct 01;10:90
pubmed: 20920306
J Psychiatr Res. 2011 Nov;45(11):1445-52
pubmed: 21722920
Am J Psychiatry. 2020 Aug 1;177(8):671-685
pubmed: 32741287
Syst Rev. 2021 Jun 9;10(1):171
pubmed: 34108032
Syst Rev. 2020 Nov 20;9(1):262
pubmed: 33218366
Cochrane Database Syst Rev. 2011 Dec 07;(12):CD006528
pubmed: 22161405
Syst Rev. 2021 Aug 13;10(1):227
pubmed: 34389045
BMJ Open. 2016 Aug 12;6(8):e011890
pubmed: 27519923
BMJ. 2008 Apr 26;336(7650):924-6
pubmed: 18436948
Biometrics. 1994 Dec;50(4):1088-101
pubmed: 7786990
CMAJ. 2003 Sep 30;169(7):677-80
pubmed: 14517128
Eur J Pharmacol. 1997 Dec 11;340(2-3):249-58
pubmed: 9537821
BMJ. 2008 May 3;336(7651):992-4
pubmed: 18456630
BMC Med Res Methodol. 2017 Dec 6;17(1):162
pubmed: 29207961
Syst Rev. 2020 May 9;9(1):108
pubmed: 32386514
Health Policy. 1996 Jul;37(1):53-72
pubmed: 10158943
Stat Med. 2006 Oct 30;25(20):3443-57
pubmed: 16345038
Br J Psychiatry. 1979 Apr;134:382-9
pubmed: 444788
Lancet. 2018 Apr 7;391(10128):1357-1366
pubmed: 29477251
Acta Psychiatr Scand. 2015 Jan;131(1):51-60
pubmed: 24954156
CNS Spectr. 2019 Feb;24(1):22-29
pubmed: 30468135
Philos Trans R Soc Lond B Biol Sci. 2012 Sep 5;367(1601):2378-81
pubmed: 22826338
J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62
pubmed: 14399272
BMC Med Res Methodol. 2014 Nov 21;14:120
pubmed: 25416419
Int J Epidemiol. 2002 Feb;31(1):140-9
pubmed: 11914310
BMJ. 1997 Sep 13;315(7109):629-34
pubmed: 9310563
Contemp Clin Trials. 2015 Jul;43:60-2
pubmed: 25979317
J Clin Psychiatry. 2015 Feb;76(2):155-62
pubmed: 25742202
Syst Rev. 2015 Jan 01;4:1
pubmed: 25554246
BMJ Open. 2019 Jun 27;9(6):e024886
pubmed: 31248914
BMJ. 2022 Aug 2;378:e067606
pubmed: 35918097
Intensive Care Med. 2018 Oct;44(10):1603-1612
pubmed: 30132025
Clin Epidemiol. 2010 Aug 09;2:57-66
pubmed: 20865104
BMJ. 2020 Sep 3;370:m3200
pubmed: 32883743
Int J Epidemiol. 2009 Feb;38(1):276-86
pubmed: 18824467
J Clin Epidemiol. 2008 Aug;61(8):763-9
pubmed: 18411040
Psychother Psychosom. 2017;86(3):141-149
pubmed: 28490031
Neuropsychiatr Dis Treat. 2018 May 22;14:1339-1350
pubmed: 29872301
BMC Med Res Methodol. 2009 Dec 30;9:86
pubmed: 20042080
Biol Psychiatry. 1996 May 15;39(10):896-9
pubmed: 8860192
BMC Psychiatry. 2017 Feb 8;17(1):58
pubmed: 28178949
BMJ. 2003 Sep 6;327(7414):557-60
pubmed: 12958120