Cargando…

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

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 reduc...

Descripción completa

Detalles Bibliográficos
Autores principales: Jørgensen, Caroline Kamp, Juul, Sophie, Siddiqui, Faiza, Horowitz, Mark Abie, Moncrieff, Joanna, Munkholm, Klaus, Hengartner, Michael Pascal, Kirsch, Irving, Gluud, Christian, Jakobsen, Janus Christian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10061867/
https://www.ncbi.nlm.nih.gov/pubmed/36991504
http://dx.doi.org/10.1186/s13643-023-02221-5
_version_ 1785017380356751360
author Jørgensen, Caroline Kamp
Juul, Sophie
Siddiqui, Faiza
Horowitz, Mark Abie
Moncrieff, Joanna
Munkholm, Klaus
Hengartner, Michael Pascal
Kirsch, Irving
Gluud, Christian
Jakobsen, Janus Christian
author_facet Jørgensen, Caroline Kamp
Juul, Sophie
Siddiqui, Faiza
Horowitz, Mark Abie
Moncrieff, Joanna
Munkholm, Klaus
Hengartner, Michael Pascal
Kirsch, Irving
Gluud, Christian
Jakobsen, Janus Christian
author_sort Jørgensen, Caroline Kamp
collection PubMed
description 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13643-023-02221-5.
format Online
Article
Text
id pubmed-10061867
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-100618672023-03-31 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 Syst Rev Protocol 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13643-023-02221-5. BioMed Central 2023-03-30 /pmc/articles/PMC10061867/ /pubmed/36991504 http://dx.doi.org/10.1186/s13643-023-02221-5 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Protocol
Jørgensen, Caroline Kamp
Juul, Sophie
Siddiqui, Faiza
Horowitz, Mark Abie
Moncrieff, Joanna
Munkholm, Klaus
Hengartner, Michael Pascal
Kirsch, Irving
Gluud, Christian
Jakobsen, Janus Christian
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10061867/
https://www.ncbi.nlm.nih.gov/pubmed/36991504
http://dx.doi.org/10.1186/s13643-023-02221-5
work_keys_str_mv AT jørgensencarolinekamp therisksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT juulsophie therisksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT siddiquifaiza therisksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT horowitzmarkabie therisksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT moncrieffjoanna therisksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT munkholmklaus therisksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT hengartnermichaelpascal therisksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT kirschirving therisksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT gluudchristian therisksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT jakobsenjanuschristian therisksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT jørgensencarolinekamp risksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT juulsophie risksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT siddiquifaiza risksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT horowitzmarkabie risksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT moncrieffjoanna risksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT munkholmklaus risksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT hengartnermichaelpascal risksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT kirschirving risksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT gluudchristian risksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis
AT jakobsenjanuschristian risksofadverseeventswithvenlafaxineandmirtazapineversusactiveplaceboplaceboornointerventionforadultswithmajordepressivedisorderaprotocolfortwoseparatesystematicreviewswithmetaanalysisandtrialsequentialanalysis