Study of Mirtazapine for Agitation in Dementia

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sussex
• Collaborators: Alzheimer's Society; Birmingham and Solihull Mental Health NHS Foundation Trust; London School of Economics and Political Science; Norwich Clinical Trials Unit; The Centre for Dementia Studies, Brighton and Sussex Medical School and SPFT; University College, London; University of Cambridge; University of East Anglia; University of Manchester; University of Newcastle Upon-Tyne
• Treatments: Carbamazepine; Mianserin; Mirtazapine

Criteria

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.