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Study, Nov/18: Combining mirtazapine w/SSRIs/SNRIs - treatment-resistant depr.


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The full title of this UK/Canadian study is "Combining mirtazapine with SSRIs or SNRIs for treatment-resistant depression: the MIR RCT".

 

https://www.ncbi.nlm.nih.gov/pubmed/30468145

 

RESULTS:

 

There were 480 patients randomised to the trial (mirtazapine and usual care, n = 241; placebo and usual care, n = 239), of whom 431 patients (89.8%) were followed up at 12 weeks. BDI-II scores at 12 weeks were lower in the mirtazapine group than the placebo group after adjustment for baseline BDI-II score and minimisation and stratification variables [difference -1.83 points, 95% confidence interval (CI) -3.92 to 0.27 points; p = 0.087]. This was smaller than the minimum clinically important difference and the CI included the null. The difference became smaller at subsequent time points (24 weeks: -0.85 points, 95% CI -3.12 to 1.43 points; 12 months: 0.17 points, 95% CI -2.13 to 2.46 points). More participants in the mirtazapine group withdrew from the trial medication, citing mild AEs (46 vs. 9 participants).

 

CONCLUSIONS:

 

This study did not find convincing evidence of a clinically important benefit for mirtazapine in addition to a SSRI or a SNRI antidepressant over placebo in primary care patients with TRD. There was no evidence that the addition of mirtazapine was a cost-effective use of NHS resources. GPs and patients were concerned about adding an additional antidepressant.

 

LIMITATIONS:

 

Voluntary unblinding for participants after the primary outcome at 12 weeks made interpretation of longer-term outcomes more difficult.

 

FUTURE WORK:

 

Treatment-resistant depression remains an area of important, unmet need, with limited evidence of effective treatments. Promising interventions include augmentation with atypical antipsychotics and treatment using transcranial magnetic stimulation.

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