Trial reportLancet (London, England)2021
Study of mirtazapine for agitated behaviours in dementia (SYMBAD): a randomised, double-blind, placebo-controlled trial.
Trial report in Lancet (London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03031184 (A Pragmatic, Multi Centre, Double-blind, Placebo Controlled Randomised Trial to Assess the Safety, Clinical and Cost Effectiveness of Mirtazapine in Patients With Alzheimer's Disease), which is not on this map. Cited by 38 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Pragmatic, Multi Centre, Double-blind, Placebo Controlled Randomised Trial to Assess the Safety, Clinical and Cost Effectiveness of Mirtazapine in Patients With Alzheimer's Disease (AD) and Agitated Behaviours
Who cites it
38 citing papers in PubMed, 4 syntheses or guidelines pooled it, 77 citations in OpenAlex.
- Efficacy and safety of cannabinoid-based interventions for behavioral and cognitive symptoms in dementia: systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Pooled it
- Evaluating the Use of Anxiety Patient-Reported Outcome Measures (PROMs) in Dementia Clinical Trials: A Systematic Review.Health expectations : an international journal of public participation in health care and health policy · 2026Pooled it
- Reduction and prevention of agitation in persons with neurocognitive disorders: an international psychogeriatric association consensus algorithm.International psychogeriatrics · 2024Guideline
- Comparative efficacy and safety of antidepressant therapy for the agitation of dementia: A systematic review and network meta-analysis.Frontiers in aging neuroscience · 2023Pooled it
- Sativex (nabiximols) for the treatment of Agitation & Aggression in Alzheimer's dementia in UK nursing homes: a randomised, double-blind, placebo-controlled feasibility trial.Age and ageing · 2025Trial
- 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 technology assessment (Winchester, England) · 2023Trial
- Differential race effects of the tailored activity program (TAP) on dementia-related behaviors: A randomized controlled trial.Journal of the American Geriatrics Society · 2022Trial
- Symptomatic treatment for Alzheimer disease: current evidence and future directions.Nature reviews. Neurology · 2026Review
- Pharmacological management of agitation in dementia: An evidence-based review with expert consensus.Journal of the Chinese Medical Association : JCMA · 2026Review
- Neuropsychiatric symptoms in Alzheimer's disease: Bridging mechanisms, management, and emerging innovations.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Review
- Exploring Autophagy Inducing Molecules: Targeting Diverse Pathways in Alzheimer's Disease Management.Medicinal research reviews · 2026Review
- Mirtazapine revisited: new therapeutic perspectives and formulation advances.Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- Persistent Delirium in the Elderly: A Case Report and Review of Multifactorial Contributors and Management Challenges.Case reports in psychiatry · 2026Article
- Apathy and cognitive decline as the first presentation of SLE-associated vascular dementia: a case report.Neuropsychiatrie : Klinik, Diagnostik, Therapie und Rehabilitation : Organ der Gesellschaft Osterreichischer Nervenarzte und Psychiater · 2025Article
- Review
- Leveraging multiomic approaches to elucidate mechanisms of heterogeneity in Alzheimer's disease: Neuropsychiatric symptoms, co-pathologies, and sex differences.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Review
- MEDICATION EXPOSURE AND NEURODEGENERATIVE DISEASE RISK ACROSS NATIONAL BIOBANKS.medRxiv : the preprint server for health sciences · 2025Article
- Treatment of agitation in dementia - a systematic review.International journal of emergency medicine · 2025Article
- Emerging Pharmacological Approaches for Psychosis and Agitation in Alzheimer's Disease.CNS drugs · 2025Review
- Noradrenergic therapies in neurodegenerative disease: from symptomatic to disease modifying therapy?Brain communications · 2025Review
Corrections and comments
- Commented on by
Authors and funding
23 authors at 15 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAgitation is common in people with dementia and negatively affects the quality of life of both people with dementia and carers. Non-drug patient-centred care is the first-line treatment, but there is a need for other treatment when this care is not effective. Current evidence is sparse on safer and effective alternatives to antipsychotics. We assessed the efficacy and safety of mirtazapine, an antidepressant prescribed for agitation in dementia.
methodsThis parallel-group, double-blind, placebo-controlled trial-the Study of Mirtazapine for Agitated Behaviours in Dementia trial (SYMBAD)-was done in 26 UK centres. Participants had probable or possible Alzheimer's disease, agitation unresponsive to non-drug treatment, and a Cohen-Mansfield Agitation Inventory (CMAI) score of 45 or more. They were randomly assigned (1:1) to receive either mirtazapine (titrated to 45 mg) or placebo. The primary outcome was reduction in CMAI score at 12 weeks. This trial is registered with ClinicalTrials.gov, NCT03031184, and ISRCTN17411897.
findingsBetween 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).
interpretationThis 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.
fundingUK National Institute for Health Research Health Technology Assessment Programme.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.