HTA Study of Antidepressants for Depression in Dementia: A definitive multi-centre pragmatic randomised controlled double-blind trial of the clinical and cost effectiveness of mirtazapine and sertraline versus placebo for the treatment of depression in dementia presenting in secondary care

King's College London (UK)0 个研究点目标入组 507 人开始时间: 2006年3月2日最近更新: 2015年1月13日

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•We have designed this study as a pragmatic trial of effectiveness in routine clinical practice. We wish to minimise exclusions from the study in order to maximise the generalisability of the data generated.
•The criteria for inclusion are set to be as close to clinical practice as possible. For this reason we do not specify the use of anything other than clinical diagnoses of dementia and depression since standardised instruments (other than the Mini-Mental State Examination [MMSE] as a measure of severity) are not used in routine practice. A detailed characterisation of cases using standardised tools will be completed at the research assessment. We will recruit those in whom a secondary care doctor makes at the point of referral to the RW:
•1. A clinical diagnosis of mild to moderate probable or possible Alzheimer's Disease
•2. A co-existing depressive illness likely to need treatment with antidepressants
•3. Depression should have a duration of more than four weeks

•We wish to minimise exclusions. We will exclude from the trial those in whom a secondary care doctor finds at the point of referral to the RW are:
•1. Currently taking antidepressants
•2 Those with severe dementia (defined as MMSE >7)
•3. The case is considered as being too critical to be randomised (e.g. because of suicide risk)
•4. Displays absolute contraindications to one or more of the trial treatments
•5. Not in another trial
•6. Those where there is no identifiable family carer or other informant (e.g. a formal/professional carer who spends sufficient time with the person with dementia to be able to give an informed opinion) to give collateral information
•We will further exclude from the trial those in whom the RW finds have a Cornell score <8 at the point of randomisation.

发起方

King's College London (UK)