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Duloxetine versus 'active' placebo, placebo or no intervention for major depressive disorder; a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis

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@article{cd7d9aa486ba44e3949aff658a0ab52f,
title = "Duloxetine versus 'active' placebo, placebo or no intervention for major depressive disorder; a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis",
abstract = "BACKGROUND: Major depression significantly impairs quality of life, increases the risk of suicide, and poses tremendous economic burden on individuals and societies. Duloxetine, a serotonin norepinephrine reuptake inhibitor, is a widely prescribed antidepressant. The effects of duloxetine have, however, not been sufficiently assessed in earlier systematic reviews and meta-analyses.METHODS/DESIGN: A systematic review will be performed including randomised clinical trials comparing duloxetine with 'active' placebo, placebo or no intervention for adults with major depressive disorder. Bias domains will be assessed, an eight-step procedure will be used to assess if the thresholds for clinical significance are crossed. We will conduct meta-analyses. Trial sequential analysis will be conducted to control random errors, and the certainty of the evidence will be assessed using GRADE. To identify relevant trials, we will search Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, PsycINFO, Science Citation Index Expanded, Social Sciences Citation Index, Conference Proceedings Citation Index-Science and Conference Proceedings Citation Index-Social Science & Humanities. We will also search Chinese databases and Google Scholar. We will search all databases from their inception to the present. Two review authors will independently extract data and perform risk of bias assessment. Primary outcomes will be the difference in mean depression scores on Hamilton Depression Rating Scale between the intervention and control groups and serious adverse events. Secondary outcomes will be suicide, suicide-attempts, suicidal ideation, quality of life and non-serious adverse events.DISCUSSION: No former systematic review has systematically assessed the beneficial and harmful effects of duloxetine taking into account both the risks of random errors and the risks of systematic errors. Our review will help clinicians weigh the benefits of prescribing duloxetine against its adverse effects and make informed decisions.SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2016 CRD42016053931.",
keywords = "Adult, Antidepressive Agents/adverse effects, Depressive Disorder, Major/drug therapy, Duloxetine Hydrochloride/therapeutic use, Humans, Meta-Analysis as Topic, Quality of Life, Randomized Controlled Trials as Topic, Suicidal Ideation, Systematic Reviews as Topic, Anti-depressants, Adverse effects, Duloxetine, Meta-analysis",
author = "Faiza Siddiqui and Marija Barbateskovic and Sophie Juul and Katakam, {Kiran Kumar} and Klaus Munkholm and Christian Gluud and Jakobsen, {Janus Christian}",
year = "2021",
month = jun,
day = "9",
doi = "10.1186/s13643-021-01722-5",
language = "English",
volume = "10",
pages = "171",
journal = "Systematic Reviews",
issn = "2046-4053",
publisher = "BioMed Central Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - Duloxetine versus 'active' placebo, placebo or no intervention for major depressive disorder; a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis

AU - Siddiqui, Faiza

AU - Barbateskovic, Marija

AU - Juul, Sophie

AU - Katakam, Kiran Kumar

AU - Munkholm, Klaus

AU - Gluud, Christian

AU - Jakobsen, Janus Christian

PY - 2021/6/9

Y1 - 2021/6/9

N2 - BACKGROUND: Major depression significantly impairs quality of life, increases the risk of suicide, and poses tremendous economic burden on individuals and societies. Duloxetine, a serotonin norepinephrine reuptake inhibitor, is a widely prescribed antidepressant. The effects of duloxetine have, however, not been sufficiently assessed in earlier systematic reviews and meta-analyses.METHODS/DESIGN: A systematic review will be performed including randomised clinical trials comparing duloxetine with 'active' placebo, placebo or no intervention for adults with major depressive disorder. Bias domains will be assessed, an eight-step procedure will be used to assess if the thresholds for clinical significance are crossed. We will conduct meta-analyses. Trial sequential analysis will be conducted to control random errors, and the certainty of the evidence will be assessed using GRADE. To identify relevant trials, we will search Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, PsycINFO, Science Citation Index Expanded, Social Sciences Citation Index, Conference Proceedings Citation Index-Science and Conference Proceedings Citation Index-Social Science & Humanities. We will also search Chinese databases and Google Scholar. We will search all databases from their inception to the present. Two review authors will independently extract data and perform risk of bias assessment. Primary outcomes will be the difference in mean depression scores on Hamilton Depression Rating Scale between the intervention and control groups and serious adverse events. Secondary outcomes will be suicide, suicide-attempts, suicidal ideation, quality of life and non-serious adverse events.DISCUSSION: No former systematic review has systematically assessed the beneficial and harmful effects of duloxetine taking into account both the risks of random errors and the risks of systematic errors. Our review will help clinicians weigh the benefits of prescribing duloxetine against its adverse effects and make informed decisions.SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2016 CRD42016053931.

AB - BACKGROUND: Major depression significantly impairs quality of life, increases the risk of suicide, and poses tremendous economic burden on individuals and societies. Duloxetine, a serotonin norepinephrine reuptake inhibitor, is a widely prescribed antidepressant. The effects of duloxetine have, however, not been sufficiently assessed in earlier systematic reviews and meta-analyses.METHODS/DESIGN: A systematic review will be performed including randomised clinical trials comparing duloxetine with 'active' placebo, placebo or no intervention for adults with major depressive disorder. Bias domains will be assessed, an eight-step procedure will be used to assess if the thresholds for clinical significance are crossed. We will conduct meta-analyses. Trial sequential analysis will be conducted to control random errors, and the certainty of the evidence will be assessed using GRADE. To identify relevant trials, we will search Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, PsycINFO, Science Citation Index Expanded, Social Sciences Citation Index, Conference Proceedings Citation Index-Science and Conference Proceedings Citation Index-Social Science & Humanities. We will also search Chinese databases and Google Scholar. We will search all databases from their inception to the present. Two review authors will independently extract data and perform risk of bias assessment. Primary outcomes will be the difference in mean depression scores on Hamilton Depression Rating Scale between the intervention and control groups and serious adverse events. Secondary outcomes will be suicide, suicide-attempts, suicidal ideation, quality of life and non-serious adverse events.DISCUSSION: No former systematic review has systematically assessed the beneficial and harmful effects of duloxetine taking into account both the risks of random errors and the risks of systematic errors. Our review will help clinicians weigh the benefits of prescribing duloxetine against its adverse effects and make informed decisions.SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2016 CRD42016053931.

KW - Adult

KW - Antidepressive Agents/adverse effects

KW - Depressive Disorder, Major/drug therapy

KW - Duloxetine Hydrochloride/therapeutic use

KW - Humans

KW - Meta-Analysis as Topic

KW - Quality of Life

KW - Randomized Controlled Trials as Topic

KW - Suicidal Ideation

KW - Systematic Reviews as Topic

KW - Anti-depressants

KW - Adverse effects

KW - Duloxetine

KW - Meta-analysis

UR - http://www.scopus.com/inward/record.url?scp=85107594164&partnerID=8YFLogxK

U2 - 10.1186/s13643-021-01722-5

DO - 10.1186/s13643-021-01722-5

M3 - Journal article

C2 - 34108032

VL - 10

SP - 171

JO - Systematic Reviews

JF - Systematic Reviews

SN - 2046-4053

IS - 1

M1 - 171

ER -

ID: 67052163