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Abstract
Objective. To examine suicidal behaviour risk in the short-term placebo-controlled studies of mirtazapine in Major Depressive Disorder (MDD). Method. Longitudinal Generalized Estimating Equations analyses were performed on pooled data from 15 placebo-controlled, randomized, double-blind, short-term trials of mirtazapine, using the suicide item scores from the Hamilton Depression Rating Scale (HAMD) as a proxy outcome measure for suicidality risk. Results. The overall analysis using the convention that a patient is at risk if the HAMD suicide item score is ≥3, and excluding patients at risk at baseline, demonstrated a statistically significantly lower risk for mirtazapine- compared to placebo-treated patients on the HAMD (odds ratio mirtazapine versus placebo 0.38; 95% confidence interval 0.21-0.66; P= 0.0008). Conclusion. Our results based on pooled data from 15 placebo-controlled, short-term studies of mirtazapine in MDD using the suicide item scores from the HAMD as a proxy outcome measure for suicidality risk, demonstrate that mirtazapine was associated with statistically significantly lower suicidality risk compared to placebo.
Acknowledgements
The authors acknowledge the efforts of Dr Milana Zivkov, Kingston-upon Thames, UK, for her assistance in preparing the first draft of this manuscript, revising the paper based on author feedback and styling the paper for journal submission. Editorial support was funded by N.V. Organon, Oss, The Netherlands.
Statement of Interest
Professor Kasper has received grant/research support from Eli Lilly, Lundbeck, Bristol-Myers Squibb, GlaxoSmithKline, Organon, Sepracor and Servier; has served as a consultant or on advisory boards for AstraZeneca, Bristol-Myers Squibb, GlaxoSmith-Kline, Eli Lilly, Lundbeck, Pfizer, Organon, Sepracor, Janssen, and Novartis; and has served on speakers’ bureaus for AstraZeneca, Bristol-Myers-Squibb, Eli Lily, Lundbeck, Servier, Organon, Sepracor and Janssen.
Professor Möller has received grant/research support from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Eisai, GlaxoSmithKline, Janssen Cilag, Lund-beck, Merck, Novartis, Organon, Pfizer, Sanof Aventis, Sepracor, Servier, Wyeth; has served as a consultant or on advisory boards for AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen Cilag, Lundbeck, Organon, Pfizer, Sepracor, Servier, Wyeth; and is a member of the speaker bureau for AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Eisai, GlaxoSmithKline, Janssen Cilag, Lund-beck, Organon, Pfizer, Sanof Aventis, Sepracor.
Professor Montgomery is a consultant for Astra-Zeneca, Bristol Myers Squibb, Cephalon, Glaxo-SmithKline, Johnson and Johnson, Lilly, Lundbeck, Merck, Merz, Neurim, Pfizer, Pierre Fabre, Roche, Sanof Aventis, Sepracor, Servier, Wyeth.
E.A. van der Meulen was employed by N.V. Organon, Oss, The Netherlands, at the time of the development of the analyses and the manuscript.