Basket | Login | Register

 
 
 
 

SYMBAD study

Clinical Trials Watch

Click here to download an accessible easy read version of this document.

Study Information

Scientific title

A Pragmatic, Multi Centre, Double-blind, Placebo Controlled Randomised Trial to Assess the Safety, Clinical and Cost Effectiveness of Mirtazapine or Carbamazepine in Patients With Alzheimer's Disease (AD) and Agitated Behaviours.

Study sponsor

University of Sussex

Disease

Alzheimer’s disease and agitated behaviours

Information about the drug that will be tested in the study

Name of drug

Mirtazapine and Carbamazepine

Administration

  • A starting tablet taken orally once a day
  • increasing to 2 tablets after 2 weeks
  • and up to 3 tablets after 4 weeks.

Is the drug already on the market for another medical condition?

Yes 

  • Mirtazapine is an antidepressant
  • Carbamazepine is primarily used in the treatment of epilepsy (affects the brain and causes repeated seizures) and neuropathic pain (pain caused by disorder affecting the sensory nervous system)

Will all participants receive the same drug?

Participants will be selected at random to either receive initially:

  • One tablet of 100 mg of Carbamazepine
  • One tablet of 15 mg of Mirtazapine
  • One placebo tablet (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested).

This will then be increased as described above. Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the safety, clinical and cost effectiveness of Mirtazapine and Carbamazepine in people with dementia.

How long will the treatment last?

Participants will receive the treatment for 12 weeks and will be followed up for one year (with tests at 6 months and 1 year).                         

What will your involvement entail?

During the study, participants will be asked to complete a questionnaire that will assess their agitation (this is a test called CMAI) and other tests to measure clinical variables.

Further information on the procedures can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

  • Be 18 years of age or older
  • Be diagnosed with probable Alzheimer’s disease
  • Be diagnosed with agitated behaviours

Complete a questionnaire that will assess their agitation (CMAI). To be able to participate, the score of this test should suggest that the participant has agitated behaviours (i.e. score of 45 or greater).

Who cannot participate in the study?

People cannot participate if they have:

  • A current treatment with antidepressants, anticonvulsants or antipsychotics
  • Contraindications to the administration of carbamazepine and mirtazapine
  • History of reduced ability to produce blood cells (bone marrow depression)
  • History of hepatic disorder (hepatic porphyrias)
  • Women of childbearing potential.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Where and when will the study be conducted?

European countries involved in the trial

  • United Kingdom

Estimated start date of recruitment

January 2017

Information for your doctor

EudraCT Number:

2015-003410-25

Clinicaltrials.gov identifier

NCT03031184

Study contact information

Sube Banerjee
 S.Banerjee@bsms.ac.uk   01273678472

Link to full text

https://clinicaltrials.gov/ct2/show/NCT03031184?term=symbad&rank=1

Study website

https://www.uea.ac.uk/hta-symbad/home

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on June 2017.

The pharmaceutical company running this trial (University of Sussex) has reviewed this document.

This document has been reviewed by a member of the European Working Group of People with Dementia.

 

 
 

Last Updated: Thursday 03 August 2017

 

 
 

Options