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Study of Mirtazapine or Carbamazepine for Agitation in Dementia (SYMBAD)

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ClinicalTrials.gov Identifier: NCT03031184
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This clinical trial evaluates whether Mirtazapine or Carbamazepine are more effective than placebo in treating agitation in people with dementia. The trial will assess the safety, clinical and cost effectiveness of each treatment. Participants will be randomised to receive one of the treatments for 12 weeks and will be followed up for up to one year, in this blinded trial.

Condition or disease Intervention/treatment Phase
Dementia Drug: Carbamazepine Drug: Mirtazapine Other: Placebo Phase 3

Detailed Description:

Patient-centred care, without the use of medicines is offered as a first course of treatment for agitation in dementia. However, there is a need for second line treatments when these fail, at the moment antipsychotics are commonly prescribed, as very little research has been done in to safer alternative treatments.

There are medicines available to treat agitation and/or aggression in dementia, but it is not clear which treatments work best.

This research study has been designed to help answer this, by comparing 2 medicines with a placebo (a tablet designed to look like a medicine but that has no active medicine in it) to see if either are suitable for treating agitation in dementia.

The medicines that will be tested are Mirtazapine and Carbamazepine. If participants and their family/carers agree to take part in this study, participants will be prescribed treatment for 12 weeks. Participants will then be followed up for 1 year after, with assessment sessions at 26 and 52 weeks.

Participants taking part in this study will be randomly allocated to a treatment group (selected to their treatment group by chance). The study is blinded, so this means the participant's doctor and the research team will not know which treatment the participant has been taking until after the study has ended. This is necessary so that the trial is a fair test of which treatment works best, however it is possible to find out which medicine they are taking in the event of a medical emergency.

The study is entirely voluntary and all participants wishing to join the study must complete an informed consent form (or if they lack capacity the participant's representative may do so on their behalf). Each participant must also have a nominated carer who consents to being questioned on aspects of the participant's dementia/care and their own experiences in caring for the participant.

The investigators are aiming to recruit 471 patients to the study in total from 8 different regions across the UK.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 471 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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 Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Mirtazapine
15mg of Mirtazapine over encapsulated to produce a blinded product that looks identical to the other arms. Starting dose is one capsule per day, escalating to 2 capsules per day after 2 weeks if no side effects and up to 3 capsules per day after 4 weeks.
Drug: Mirtazapine
Experimental: Carbamazepine
100mg of extended release Carbamazepine over encapsulated to produce a blinded product that looks identical to the other arms. Starting dose is one capsule per day, escalating to 2 capsules per day after 2 weeks if no side effects and up to 3 capsules per day after 4 weeks.
Drug: Carbamazepine
Other Names:
  • Tegretol XR (Extended release)
  • Tegretol slow release
Placebo Comparator: Placebo
Lactose powder encapsulated to produce a blinded product that looks identical to the other arms. Starting dose is one capsule per day, escalating to 2 capsules per day after 2 weeks if no side effects and up to 3 capsules per day after 4 weeks.
Other: Placebo
Other Name: Dummy pill

Outcome Measures

Primary Outcome Measures :
  1. Cohen Mansfield Agitation Inventory (CMAI) score (Long Form, 29 questions) [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    Measured at baseline, 6 and 12 weeks, it is the difference in the score at 12 weeks that is the primary outcome. The questions are asked of the person with dementia's carer

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  • If patients are taking cholinesterase inhibitors or memantine they must be on a stable dose (defined as three months on current dose)
  • 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), anticonvulsants, or antipsychotics. Patients must have completed treatment with these medications at least two weeks before trial drug administration.
  • Contraindications to the administration of carbamazepine and mirtazapine as per their current SmPCs
  • Patients with second degree atrioventricular block (patients with third degree heart block, with a pace maker fitted, may be included at PI discretion)
  • Patient with a history of bone marrow depression or history of hepatic porphyrias
  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031184

Contact: Sube Banerjee, Professsor 01273678472 S.Banerjee@bsms.ac.uk

United Kingdom
Sube Banerjee Recruiting
Brighton, Sussex, United Kingdom, BN1 9RY
Contact: Sub Banerjee, MD    01273877896    s.banerjee@bsms.ac.uk   
Principal Investigator: Naji Tabet, MD         
Principal Investigator: Chris Fox, MD         
Principal Investigator: Alan Thomas, MD         
Principal Investigator: Iracema Leroi, MD         
Principal Investigator: Gill Livingston, MD         
Principal Investigator: Peter Bentham, MD         
Principal Investigator: Clive Ballard, MD         
Principal Investigator: Annabel Price, MD         
Principal Investigator: Ramin Nilforooshan, MD         
Sponsors and Collaborators
University of Sussex
Norwich Clinical Trials Unit
University of East Anglia
University of Cambridge
University College, London
London School of Economics and Political Science
University of Manchester
University of Newcastle Upon-Tyne
Birmingham and Solihull Mental Health NHS Foundation Trust
Alzheimer's Society
The Centre for Dementia Studies, Brighton and Sussex Medical School and SPFT
Principal Investigator: Sube Banerjee, Professor Brighton and Sussex Medical School
More Information

Responsible Party: University of Sussex
ClinicalTrials.gov Identifier: NCT03031184     History of Changes
Other Study ID Numbers: 15/SC/0606
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No plans to routinely disseminate this data. The Trial Management Group (and in future, the funder) may consider individual requests made in writing.

Keywords provided by University of Sussex:
Agitated behaviours
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation
Antimanic Agents
Tranquilizing Agents