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Item-based analysis of the effects of duloxetine in depression: a patient-level post hoc study.

Journal article
Authors Alexander Lisinski
Fredrik Hieronymus
Jakob Näslund
Staffan Nilsson
Elias Eriksson
Published in Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology
Volume 45
Pages 553–560
ISSN 1740-634X
Publication year 2020
Published at Department of Mathematical Sciences
Institute of Biomedicine
Institute of Neuroscience and Physiology, Department of Pharmacology
Pages 553–560
Language en
Keywords Duloxetine in depression
Subject categories Pharmacology and Toxicology, Neurosciences


Oft-cited trial-level meta-analyses casting doubt on the usefulness of antidepressants have been based on re-analyses of to what extent the active drug has outperformed placebo in reducing the sum score of the Hamilton Depression Rating Scale (HDRS-17-sum) in clinical trials. Recent studies, however, suggest patient-level analyses of individual HDRS items to be more informative when assessing the efficacy of an antidepressant. To shed further light on both symptom-reducing and symptom-aggravating effects of a serotonin and noradrenaline reuptake inhibitor, duloxetine, when used for major depression in adults, we hence applied this approach to re-analyse data from 13 placebo-controlled trials. In addition, using patient-level data from 28 placebo-controlled trials of selective serotonin reuptake inhibitors (SSRIs), the response profile of duloxetine was compared to that of these drugs. Duloxetine induced a robust reduction in depressed mood that was not dependent on baseline severity and not caused by side-effects breaking the blind. A beneficial effect on depressed mood was at hand already after one week; when outcome was assessed using HDRS-17-sum as effect parameter, this early response was however masked by a concomitant deterioration with respect to adverse event-related items. No support for a suicide-provoking effect of duloxetine was obtained. The response profile of duloxetine was strikingly similar to that of the SSRIs. We conclude that the use of HDRS-17-sum as effect parameter underestimates the true efficacy and masks an early effect of duloxetine on core symptoms of depression. No support for major differences between duloxetine and SSRIs in clinical profile were obtained.

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