Mirtazapine added to selective serotonin reuptake inhibitors for treatment-resistant depression in primary care (MIR trial): Study protocol for a randomised controlled trial

Tallon, Debbie; Wiles, Nicola; Campbell, John; Chew-Graham, Carolyn; Dickens, Chris; Macleod, Una; Peters, Tim J.; Lewis, Glyn; Anderson, Ian M.; Gilbody, Simon; Hollingworth, William; Davies, Simon; Kessler, David

Abstract

© 2016 Tallon et al. Background: People with depression are usually managed in primary care and antidepressants are often the first-line treatment, but only one third of patients respond fully to a single antidepressant. This paper describes the protocol for a randomised controlled trial (MIR) to investigate the extent to which the addition of the antidepressant mirtazapine is effective in reducing the symptoms of depression compared with placebo in patients who are still depressed after they have been treated with a selective serotonin reuptake inhibitor (SSRI) or serotonin and noradrenaline reuptake inhibitor (SNRI) for at least 6weeks in primary care. Methods/Design: MIR is a two-parallel group, multi-centre, pragmatic, placebo controlled, randomised trial with allocation at the level of the individual. Eligible participants are those who: are aged 18years or older; are currently taking an SSRI/SNRI antidepressant (for at least 6weeks at an adequate dose); score ≥14 on the Beck Depression Inventory (BDI-II); have adhered to their medication; and meet ICD-10 criteria for depression (assessed using the Clinical Interview Schedule-Revised version). Participants who give written, informed consent, will be randomised to receive either oral mirtazapine or matched placebo, starting at 15mg daily for 2weeks and increasing to 30mg daily thereafter, for up to 12months (to be taken in addition to their usual antidepressant). Participants, their GPs, and the research team will all be blind to the allocation. The primary outcome will be depression symptoms at 12weeks post randomisation, measured as a continuous variable using the BDI-II. Secondary outcomes (measured at 12, 24 and 52weeks) include: response (reduction in depressive symptoms (BDI-II score) of at least 50% compared to baseline); remission of depression symptoms (BDI-II

Citation

Tallon, D., Wiles, N., Campbell, J., Chew-Graham, C., Dickens, C., Macleod, U., Peters, T. J., Lewis, G., Anderson, I. M., Gilbody, S., Hollingworth, W., Davies, S., & Kessler, D. (2016). Mirtazapine added to selective serotonin reuptake inhibitors for treatment-resistant depression in primary care (MIR trial): Study protocol for a randomised controlled trial. Trials, 17(1), Article 66. https://doi.org/10.1186/s13063-016-1199-2

• Journal Article Type: Article
• Acceptance Date: Jan 26, 2016
• Online Publication Date: Feb 3, 2016
• Publication Date: Feb 3, 2016
• Deposit Date: Apr 19, 2022
• Publicly Available Date: Apr 20, 2022
• Journal: Trials
• Print ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 17
• Issue: 1
• Article Number: 66
• DOI: https://doi.org/10.1186/s13063-016-1199-2
• Keywords: Depression; Treatment-resistant; Antidepressants; Mirtazapine; Selective serotonin reuptake inhibitors
• Public URL: https://hull-repository.worktribe.com/output/3607618