drugset / Trial / NCT03031184
Study of Mirtazapine for Agitation in Dementia
Phase 3
Completed
207 enrolled
University of Sussex
Alzheimer's Society · collabBirmingham and Solihull Mental Health NHS Foundation Trust · collabLondon School of Economics and Political Science · collabNorwich Clinical Trials Unit · collabThe Centre for Dementia Studies, Brighton and Sussex Medical School and SPFT · collabUniversity College, London · collabUniversity of Cambridge · collabUniversity of East Anglia · collabUniversity of Manchester · collabUniversity of Newcastle Upon-Tyne · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This clinical trial evaluates whether Mirtazapine is more effective than placebo in treating agitation in people with dementia. The trial will assess the safety, clinical and cost effectiveness of the treatment. Participants will be randomised to receive either Mirtazapine or placebo for 12 weeks and will be followed up for up to one year, in this blinded trial.
Timeline
- Start
- 2017-01
- Primary completion
- 2020-06
- Completion
- 2021-03
Outcome
Missed primary endpoint
paper 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). PMID 34688369 ↗
paper This trial found no benefit of mirtazapine compared with placebo PMID 34688369 ↗
Publications
- Banerjee S, Farina N, Henderson C, High J, Stirling S, Shepstone L, Fountain J, Ballard C, Bentham P, Burns A, Fox C, Francis P, Howard R, Knapp M, Leroi I, Livingston G, Nilforooshan R, Nurock S, O'Brien J, Price A, Thomas AJ, Swart AM, Telling T, Tabet N. A pragmatic, multicentre, double-blind, placebo-controlled randomised trial to assess the safety, clinical and cost-effectiveness of mirtazapine and carbamazepine in people with Alzheimer's disease and agitated behaviours: the HTA-SYMBAD trial. Health Technol Assess. 2023 Oct;27(23):1-108. doi: 10.3310/VPDT7105.
- Banerjee S, High J, Stirling S, Shepstone L, Swart AM, Telling T, Henderson C, Ballard C, Bentham P, Burns A, Farina N, Fox C, Francis P, Howard R, Knapp M, Leroi I, Livingston G, Nilforooshan R, Nurock S, O'Brien J, Price A, Thomas AJ, Tabet N. Study of mirtazapine for agitated behaviours in dementia (SYMBAD): a randomised, double-blind, placebo-controlled trial. Lancet. 2021 Oct 23;398(10310):1487-1497. doi: 10.1016/S0140-6736(21)01210-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirtazapine | Other / unclassified | 45 mg | — |