SYMBAD

CompletedPhase 3

Study of Mirtazapine for Agitation in Dementia

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

Lead sponsor

University of Sussex

Asset

Mirtazapine

Listed sites

Recruiting sites

Enrollment

207

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Cohen Mansfield Agitation Inventory (CMAI) score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID15/SC/0606

NCT IDNCT03031184

Timeline

Milestones

Study start2017-01actual (month precision)

Study first posted2017-01-25estimated

Primary completion2020-06actual (month precision)

Study completion2021-03actual (month precision)

Last update posted2021-04-19actual

Assets

Drug assets

Mirtazapine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with a clinical diagnosis of probable or possible Alzheimer's Disease using National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria (McKhann et Al, 1984)

•a diagnosis of co-existing agitated behaviours

•evidence that the agitated behaviours have not responded to management according to the AS/DH algorithm (AS/DH, 2011)

•An assessment of Cohen Mansfield Agitation Inventory (CMAI; Cohen-Mansfield et al, 1989, Long form) score of 45 or greater

•Written informed consent to enter and be randomised into the trial

•Availability of a suitable informant (consenting identifiable family carer or paid carer) to provide information on carer-completed outcome measures and who consents to take part in the trial

Exclusion criteria

•Current treatment with antidepressants (including MAOIs) or antipsychotics. Normal clinical practice should be followed, with an appropriate washout period before trial drug administration. For MAOIs this should be least two weeks.

•Contraindications to the administration of mirtazapine as per the current SmPC

•Patients with second degree atrioventricular block (patients with third degree heart block, with a pace maker fitted, may be included at PI discretion)

•Cases too critical for randomisation (ie where there is a suicide risk or where the patient presents a risk of harm to others)

•Female subjects under the age of 55 of childbearing potential, defined as follows: postmenopausal females who have not had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH>40mIU/ml or females who have not had a hysterectomy or bilateral oophorectomy at least 6 weeks prior to enrolment.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

Cohen Mansfield Agitation Inventory (CMAI) score (Long Form, 29 questions)

Time frame:Baseline, 6 weeks, 12 weeks

descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.