PROTOCOL: A cohort study examining the association between mirtazapine and mortality risk in adults with a diagnosis of depression

Joseph, Rebecca M; Jack, Ruth H; Morriss, Richard; Knaggs, Roger D; Hollis, Chris; Hippisley-Cox, Julia; Coupland, Carol

Authors

REBECCA JOSEPH REBECCA.JOSEPH@NOTTINGHAM.AC.UK
Ktp Associatehealth Data Scientist

RUTH JACK Ruth.Jack@nottingham.ac.uk
Senior Research Fellow

RICHARD MORRISS richard.morriss@nottingham.ac.uk
Professor of Psychiatry & Community Mental Health

ROGER KNAGGS Roger.Knaggs@nottingham.ac.uk
Associate Professor

CHRIS HOLLIS chris.hollis@nottingham.ac.uk
Professor of Child and Adolescent Psychiatry and Digital Mental Health

Julia Hippisley-Cox

CAROL COUPLAND carol.coupland@nottingham.ac.uk
Professor of Medical Statistics

Abstract

This protocol describes a cohort study comparing the risks of mortality and serious self-harm (suicide or near-fatal deliberate self-harm) between adults with depression prescribed mirtazapine, a selective serotonin reuptake inhibitor (SSRI), amitriptyline, or venlafaxine. The study is set within English primary care electronic health records from the Clinical Practice Research Datalink (CPRD) and covers the period 01 January 2005 – 30 November 2018. The study described uses an active comparator new user design: patients are included if they are first prescribed an SSRI before being prescribed mirtazapine, a different SSRI, amitriptyline, or venlafaxine as their second antidepressant. Patients are followed from the initial prescription for the second antidepressant until an outcome (mortality, serious self-harm), end of CPRD follow-up, or study end. Inverse probability of treatment weighting is used to account for confounding variables. The protocol was submitted to the CPRD Independent Scientific Advisory Committee for review and was approved in November 2019 (protocol number 19_241).

Citation

Joseph, R. M., Jack, R. H., Morriss, R., Knaggs, R. D., Hollis, C., Hippisley-Cox, J., & Coupland, C. PROTOCOL: A cohort study examining the association between mirtazapine and mortality risk in adults with a diagnosis of depression

Deposit Date	Mar 12, 2021
Publicly Available Date	May 4, 2021
Keywords	Mirtazapine, Antidepressants, Mortality, Deliberate Self-Harm, Depression
Public URL	https://nottingham-repository.worktribe.com/output/5319824
Publisher URL	https://www.medrxiv.org/content/10.1101/2021.02.08.21250305v1
Additional Information	This article is a preprint and has not been peer-reviewed. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.