Selective Serotonin Reuptake Inhibitor SSRI antidepressant for patients in primary care who had not responded to a single antidepressant Kessler D et al BMJ 2018363k4218 Research Design ID: 1006562
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1. The Research QuestionIs Mirtazapine effective and cost effective in combination with a Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) or Selective Serotonin Reuptake Inhibitor (SSRI) antidepressant for patients in primary care who had not responded to a single antidepressant?Kessler, D et al BMJ 2018;363:k4218
2. Research Design and MethodTwo parallel group multi-centre pragmatic placebo controlled randomised trial with allocation at the level of the individualPrimary care patients taking an SSRI/SNRI for at least 6 weeksAdults with a Beck Depression Inventory (BDI) score > 13International Classification of Disease (ICD10) Depressive EpisodeRandomised to add either placebo or Mirtazapine 15mg increasing to 30mg
3. What the Research Found480 recruited (69.1% female) (89.8% followed up for 12 weeks)241 randomised to Mirtazapine and 239 to placeboMean BDI scores at baseline: Mirtazapine group 31.5, Placebo 30.690% had been on an antidepressant for 6 months or moreMain outcome: ITT analysis (adjusted) of BDI scores at 12 weeks:This study did not find convincing evidence that adding mirtazapine gives a clinically important benefitGroupsnMeanSDDifference in means95% CIpMirtazapine21418.012.3-1.83-3.92, 0.270.09Placebo21719.712.4Total N43118.812.4
4. What this means for Clinical PracticeAlthough there was a small between group difference in favour of mirtazapine, this did not reach the pre-specified minimal clinically important difference of at least 3 points on the BDI, and included the possibility of ‘no effect’. Adverse effects were more frequent in the mirtazapine group and more in this group stopped the trial medication. What this study adds: These findings challenge the growing practice of the addition of mirtazapine to SSRI or SNRI in this group of patients