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

Jørgensen, Caroline Kamp; Juul, Sophie; Siddiqui, Faiza; Horowitz, Mark Abie; Moncrieff, Joanna; Munkholm, Klaus; Hengartner, Michael Pascal; Kirsch, Irving; Gluud, Christian; Jakobsen, Janus Christian

doi:10.1186/s13643-023-02221-5

Please use this identifier to cite or link to this item: https://doi.org/10.21256/zhaw-27638

Publication type:	Article in scientific journal
Type of review:	Open peer review
Title:	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
Authors:	Jørgensen, Caroline Kamp Juul, Sophie Siddiqui, Faiza Horowitz, Mark Abie Moncrieff, Joanna Munkholm, Klaus Hengartner, Michael Pascal Kirsch, Irving Gluud, Christian Jakobsen, Janus Christian
et. al:	No
DOI:	10.1186/s13643-023-02221-5 10.21256/zhaw-27638
Published in:	Systematic Reviews
Volume(Issue):	12
Issue:	1
Page(s):	57
Issue Date:	30-Mar-2023
Publisher / Ed. Institution:	BioMed Central
ISSN:	2046-4053
Language:	English
Subjects:	Adverse effect; Adverse event; Antidepressant; Beneficial effect; Major depressive disorder; Mirtazapine; Venlafaxine; Human; Adult; Mirtazapine; Venlafaxine hydrochloride; Quality of life; Meta-analysis as topic; Review literature as topic
Subject (DDC):	615: Pharmacology and therapeutics 616.8: Neurology, diseases of nervous system
Abstract:	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.
URI:	https://digitalcollection.zhaw.ch/handle/11475/27638
Fulltext version:	Published version
License (according to publishing contract):	CC BY 4.0: Attribution 4.0 International
Departement:	Applied Psychology
Organisational Unit:	Psychological Institute (PI)
Appears in collections:	Publikationen Angewandte Psychologie

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Jørgensen, C. K., Juul, S., Siddiqui, F., Horowitz, M. A., Moncrieff, J., Munkholm, K., Hengartner, M. P., Kirsch, I., Gluud, C., & Jakobsen, J. C. (2023). 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. Systematic Reviews, 12(1), 57. https://doi.org/10.1186/s13643-023-02221-5

Jørgensen, C.K. et al. (2023) ‘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’, Systematic Reviews, 12(1), p. 57. Available at: https://doi.org/10.1186/s13643-023-02221-5.

C. K. Jørgensen et al., “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,” Systematic Reviews, vol. 12, no. 1, p. 57, Mar. 2023, doi: 10.1186/s13643-023-02221-5.

JØRGENSEN, Caroline Kamp, Sophie JUUL, Faiza SIDDIQUI, Mark Abie HOROWITZ, Joanna MONCRIEFF, Klaus MUNKHOLM, Michael Pascal HENGARTNER, Irving KIRSCH, Christian GLUUD und Janus Christian JAKOBSEN, 2023. 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. Systematic Reviews. 30 März 2023. Bd. 12, Nr. 1, S. 57. DOI 10.1186/s13643-023-02221-5

Jørgensen, Caroline Kamp, Sophie Juul, Faiza Siddiqui, Mark Abie Horowitz, Joanna Moncrieff, Klaus Munkholm, Michael Pascal Hengartner, Irving Kirsch, Christian Gluud, and Janus Christian Jakobsen. 2023. “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.” Systematic Reviews 12 (1): 57. https://doi.org/10.1186/s13643-023-02221-5.

Jørgensen, Caroline Kamp, et al. “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.” Systematic Reviews, vol. 12, no. 1, Mar. 2023, p. 57, https://doi.org/10.1186/s13643-023-02221-5.