Study of Mirtazapine for Agitation in Dementia

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.

Conditions

• Dementia

Interventions

DRUG

Mirtazapine

OTHER

Placebo

Sponsors & Collaborators

• Norwich Clinical Trials Unit

  collaborator UNKNOWN

• University of East Anglia

  collaborator OTHER

• University of Cambridge

  collaborator OTHER

• University College, London

  collaborator OTHER

• London School of Economics and Political Science

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• University of Newcastle Upon-Tyne

  collaborator OTHER

• Birmingham and Solihull Mental Health NHS Foundation Trust

  collaborator OTHER

• Alzheimer's Society

  collaborator OTHER

• The Centre for Dementia Studies, Brighton and Sussex Medical School and SPFT

  collaborator UNKNOWN

• University of Sussex

  lead OTHER

Principal Investigators

• Sube Banerjee, Professor · Brighton and Sussex Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2020-06-30

Completion

2021-03-31

Countries

• United Kingdom

Study Locations