Sertraline and mirtazapine do more harm than good for people with dementia and depression


Depression is common in patients with dementia and antidepressants are widely prescribed for this population although the evidence remains limited.

This randomised controlled trial conducted by researchers at the Institute of Psychiatry in London and published in the Lancet, explored the safety and efficacy of two widely-used drugs (sertraline and mirtazapine) in patients with dementia and depression.

Participants were old people with probable or possible Alzheimer’s disease and depression assessed as a score of 8 or more on the Cornell scale for depression in dementia (CSDD). They were randomised to one of three treatment arms:

  1. Sertraline with usual care
  2. Mirtazapine with usual care
  3. Placebo with usual care

The primary outcome was a reduction in depression according to CSDD score at 13 weeks, with follow-up to 39 weeks.

There were 326 patients randomised and assessed, 107 to sertraline, 108 to mirtazapine, and 111 to control.

The results showed that the antidepressants were no better than each other or placebo:

  • There were no significant differences in CSDD scores between sertraline and placebo (mean difference 1.17; 95% CI −0.23 to 2.58; p=0.10)
  • There were no significant differences in CSDD scores between mirtazapine and placebo (mean difference 0.01; 95% CI −1.37 to 1.38; p=0.99)
  • There were no significant differences between the two antidepressants (mean difference 1.16 95% CI; −0.25 to 2.57; p=0.11).

Side effects were more common in the groups that were taking the antidepressants:

  • Sertraline group (43%; p=0.010)
  • Mirtazapine group (41%; p=0.031)
  • Placebo control group (26%)
  • The placebo group also had fewer adverse events rated as severe (p=0.003)

The authors concluded:

Because of the absence of benefit compared with placebo and increased risk of adverse events, the present practice of use of these antidepressants, with usual care, for first-line treatment of depression in Alzheimer’s disease should be reconsidered.

Banerjee S, et al. Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial. Lancet. 2011 Jul 30;378(9789):403-11. Epub 2011 Jul 19. [PubMed abstract]

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