Abstract
BackgroundMajor 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/designA 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.DiscussionNo 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 registrationPROSPERO 2016 CRD42016053931
Highlights
Major depression significantly impairs quality of life, increases the risk of suicide, and poses tremendous economic burden on individuals and societies
Depression According to the World Health Organization (WHO), 264 million people suffer from depression around the globe [1] and major depressive disorder has been estimated to be the third leading cause of years lived with disability in both sexes [2]
Antidepressants Different classes of antidepressants are available for treatment of patients with major depressive disorder ranging from older antidepressants like mono-amine oxidase inhibitors (MAOI) and tri-cyclic antidepressants (TCA) to newer groups of drugs like selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) as summarised in Table S1 (Additional file 1)
Summary
Major depression significantly impairs quality of life, increases the risk of suicide, and poses tremendous economic burden on individuals and societies. With a 12-month prevalence of around 5.5% in high-income countries [5], major depressive disorder is a large economic burden due to decreased work productivity [6] and it significantly impairs quality of life [7, 8]. Antidepressants Different classes of antidepressants are available for treatment of patients with major depressive disorder ranging from older antidepressants like mono-amine oxidase inhibitors (MAOI) and tri-cyclic antidepressants (TCA) to newer groups of drugs like selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) as summarised in Table S1 (Additional file 1). Whilst SSRIs remain the most commonly prescribed antidepressants, there has been a consistent increase in the prescription of other antidepressants such as duloxetine [10, 11]
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