Study of Mirtazapine for Agitation in Dementia (SYMBAD)
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|ClinicalTrials.gov Identifier: NCT03031184|
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : November 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Drug: Mirtazapine Other: Placebo||Phase 3|
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 a which is currently prescribed for depression, Mirtazapine, with placebo (a tablet designed to look like a medicine but that has no active medicine in it) to see if Mirtazapine is suitable for treating agitation in dementia.
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 222 patients to the study in total from around 20 different regions across the UK.
The study was originally designed to included a second medication, called Carbamazepine, to also look at whether it would work and be safe and cost effective in agitation in dementia. Challenges in recruitment in this population resulted in the funder requesting that the available data was reviewed to July 2018, to see whether one of the arms (Mirtazapine or Carbamazepine) should be discontinued in terms of future recruitment. The independent data monitoring committee compared blinded data from both groups against placebo data and concluded that on the basis of efficacy and safety, the group, which when unblinded was found to be Carbamazepine, should be dropped. Some limited analysis will still be completed for all data collected in the Carbamazepine group, but the trial will continue now only randomising participants to Mirtazapine or placebo.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||July 2020|
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.
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 Name: Dummy pill
- 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
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|
|Brighton, Sussex, United Kingdom, BN1 9RY|
|Contact: Sube Banerjee, MD 01273877896 firstname.lastname@example.org|
|Principal Investigator: Naji Tabet, MD|
|Principal Investigator: Chris Fox, MD|
|Principal Investigator: Alan Thomas, MD|
|Principal Investigator: Ross Dunne, MD|
|Principal Investigator: Gill Livingston, MD|
|Principal Investigator: Peter Bentham, MD|
|Principal Investigator: Annabel Price, MD|
|Principal Investigator: Ramin Nilforooshan, MD|
|Principal Investigator: Carol Bannister, MD|
|Principal Investigator: Sushanth Kamath, MD|
|Principal Investigator:||Sube Banerjee, Professor||Brighton and Sussex Medical School|