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Study of mirtazapine for agitated behaviours in dementia (SYMBAD): a randomised, double-blind, placebo-controlled trial
Sube Banerjee, Juliet High, Susan Stirling, Lee Shepstone, Ann Marie Swart, Tanya Telling, Catherine Henderson, Clive Ballard et al.. Lancet (London, England), 2021-10-23
Topic: Drug trials: efficacy and safety
Between Jan 26, 2017, and March 6, 2020, 204 participants were recruited and randomised. Mean CMAI scores at 12 weeks were not significantly different between participants receiving mirtazapine and participants receiving placebo (adjusted mean difference -1·74, 95% CI -7·17 to 3·69; p=0·53). The number of controls with adverse events (65 [64%] of 102 controls) was similar to that in the mirtazapine group (67 [66%] of 102 participants receiving mirtazapine). However, there were more deaths in the mirtazapine group (n=7) by week 16 than in the control group (n=1), with post-hoc analysis suggesting this difference was of marginal statistical significance (p=0·065). This trial found no benefit of mirtazapine compared with placebo, and we observed a potentially higher mortality with use of mirtazapine. The data from this study do not support using mirtazapine as a treatment for agitation in dementia. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.
Key findings
- Between Jan 26, 2017, and March 6, 2020, 204 participants were recruited and randomised.
- Mean CMAI scores at 12 weeks were not significantly different between participants receiving mirtazapine and participants receiving placebo (adjusted mean difference -1·74, 95% CI -7·17 to 3·69; p=0·53).
- The number of controls with adverse events (65 [64%] of 102 controls) was similar to that in the mirtazapine group (67 [66%] of 102 participants receiving mirtazapine).
- However, there were more deaths in the mirtazapine group (n=7) by week 16 than in the control group (n=1), with post-hoc analysis suggesting this difference was of marginal statistical significance (p=0·065).
- This trial found no benefit of mirtazapine compared with placebo, and we observed a potentially higher mortality with use of mirtazapine.
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Study details
- Study designpost-hoc analysis
- Participants204
- Evidence strengthHigh
How this study scored 86/100
Published in a top-tier journal, and it is a randomised controlled trial. Scored zero for effect reported because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record, multi-centre collaboration and free to read, so those were left out: it earned 48 of the 56 points we could judge it on, which is 86 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 10 / 10 | Tier 1 — top-tier general journal (Lancet (London, England)) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 3 / 5 | 2021 — within 6 year(s) of the newest study here |
| Sample size | 2 / 4 | 204 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 34688369) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 48 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 48 of the 56 points we could judge it on is 86 out of 100. |
| Total | 86 / 100 | — |
What each of these 20 components measures, and what this score is not →
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APA 7th
Banerjee, S., High, J., Stirling, S., Shepstone, L., Swart, A. M., Telling, T., et al. (2021). Study of mirtazapine for agitated behaviours in dementia (SYMBAD): a randomised, double-blind, placebo-controlled trial. Lancet (London, England). https://doi.org/10.1016/s0140-6736(21)01210-1
Vancouver
Banerjee S, High J, Stirling S, Shepstone L, Swart AM, Telling T, et al. Study of mirtazapine for agitated behaviours in dementia (SYMBAD): a randomised, double-blind, placebo-controlled trial. Lancet (London, England). 2021. doi:10.1016/s0140-6736(21)01210-1. PMID: 34688369.
BibTeX
@article{banerjee2021-34688369,
author = {Banerjee, Sube and High, Juliet and Stirling, Susan and Shepstone, Lee and Swart, Ann Marie and Telling, Tanya and Henderson, Catherine and Ballard, Clive and others},
title = {{Study of mirtazapine for agitated behaviours in dementia (SYMBAD): a randomised, double-blind, placebo-controlled trial}},
journal = {Lancet (London, England)},
year = {2021},
doi = {10.1016/s0140-6736(21)01210-1},
pmid = {34688369},
url = {https://doi.org/10.1016/s0140-6736(21)01210-1}
}