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

Completed

Conditions: Depression in dementia
Mental and Behavioural Disorders
Depression

Registration Number: ISRCTN88882979

Lead Sponsor: King's College London (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 507

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Depression in dementia - CSDD (Alexopoulos et al 1988)<br>2. Costs - Client Service Receipt Inventory (CSRI; Beecham et al 2001)

Secondary Outcome Measures

Name	Time	Method
1. Disease specific quality of life - DEMQOL and DEMQOL-Proxy (Smith et al 2005)<br>2. Generic measure of quality of life - interview administered to carer (Coucill et al 2001) EQ-5D (EuroQoL Group 1990)<br>3. Withdrawal from treatment arm<br>4. Cognitive impairment - MMSE (Folstein et al 1975)<br>5. Medication adherence<br>6. Adverse events<br>7. Carer mental health - General Health Questionnaire - 12 (GHQ-12; Goldberg et al 1988)<br>8. Carer quality of life - SF-12 v2 (Ware et al 1996)<br>9. Carer burden - Zarit Carer Burden Scale (Zarit 1980)