title: Cost-effectiveness analyses for mirtazapine and sertraline in dementia: randomised controlled trial.
abstract: BACKGROUND
  Depression is a common and costly comorbidity in dementia. There are very few data on the cost-effectiveness of antidepressants for depression in dementia and their effects on carer outcomes.
  
  
  OBJECTIVE
  To evaluate the cost-effectiveness of sertraline and mirtazapine compared with placebo for depression in dementia.
  
  
  METHODS
  A pragmatic, multicentre, randomised placebo-controlled trial with a parallel cost-effectiveness analysis (trial registration: ISRCTN88882979 and EudraCT 2006-000105-38). The primary cost-effectiveness analysis compared differences in treatment costs for patients receiving sertraline, mirtazapine or placebo with differences in effectiveness measured by the primary outcome, total Cornell Scale for Depression in Dementia (CSDD) score, over two time periods: 0-13 weeks and 0-39 weeks. The secondary evaluation was a cost-utility analysis using quality-adjusted life years (QALYs) computed from the Euro-Qual (EQ-5D) and societal weights over those same periods.
  
  
  RESULTS
  There were 339 participants randomised and 326 with costs data (111 placebo, 107 sertraline, 108 mirtazapine). For the primary outcome, decrease in depression, mirtazapine and sertraline were not cost-effective compared with placebo. However, examining secondary outcomes, the time spent by unpaid carers caring for participants in the mirtazapine group was almost half that for patients receiving placebo (6.74 v. 12.27 hours per week) or sertraline (6.74 v. 12.32 hours per week). Informal care costs over 39 weeks were £1510 and £1522 less for the mirtazapine group compared with placebo and sertraline respectively.
  
  
  CONCLUSIONS
  In terms of reducing depression, mirtazapine and sertraline were not cost-effective for treating depression in dementia. However, mirtazapine does appear likely to have been cost-effective if costing includes the impact on unpaid carers and with quality of life included in the outcome. Unpaid (family) carer costs were lower with mirtazapine than sertraline or placebo. This may have been mediated via the putative ability of mirtazapine to ameliorate sleep disturbances and anxiety. Given the priority and the potential value of supporting family carers of people with dementia, further research is warranted to investigate the potential of mirtazapine to help with behavioural and psychological symptoms in dementia and in supporting carers.
authors.affiliation: Brighton & Sussex Medical School, University of Sussex, Brighton, East Sussex, UK. s.banerjee@bsms.ac.uk
authors.forename: Renee
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authors.lastname: Romeo
authors.forename: Martin
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authors.lastname: Knapp
authors.forename: Jennifer
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authors.forename: Michael
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authors.forename: Clive
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authors.lastname: Ballard
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authors.lastname: Baldwin
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authors.lastname: Bentham
authors.forename: Alistair
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authors.lastname: Burns
authors.forename: Chris
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authors.lastname: Fox
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authors.lastname: Holmes
authors.forename: Cornelius
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authors.lastname: Katona
authors.forename: Claire
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authors.lastname: Lawton
authors.forename: James
authors.initials: J
authors.lastname: Lindesay
authors.forename: Gill
authors.initials: G
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authors.forename: Niall
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authors.lastname: McCrae
authors.forename: Esme
authors.initials: E
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authors.forename: Joanna
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authors.lastname: Murray
authors.forename: Shirley
authors.initials: S
authors.lastname: Nurock
authors.forename: John
authors.initials: J
authors.lastname: O'Brien
authors.forename: Michaela
authors.initials: M
authors.lastname: Poppe
authors.forename: Alan
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authors.lastname: Thomas
authors.forename: Rebecca
authors.initials: R
authors.lastname: Walwyn
authors.forename: Kenneth
authors.initials: K
authors.lastname: Wilson
authors.forename: Sube
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authors.lastname: Banerjee
mesh_terms: D000928:Antidepressive Agents / Q000191:economics* / Q000627:therapeutic use; D017028:Caregivers / Q000191:economics; D003362:Cost-Benefit Analysis; D003704:Dementia / Q000150:complications / Q000188:drug therapy / Q000191:economics*; D003863:Depression / Q000150:complications / Q000188:drug therapy / Q000191:economics*; D017048:Health Care Costs / Q000706:statistics & numerical data; D006299:Health Services for the Aged / Q000191:economics / Q000706:statistics & numerical data*; D006801:Humans; D057194:Intention to Treat Analysis; D008803:Mianserin / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D000078785:Mirtazapine; D017063:Outcome Assessment, Health Care / Q000191:economics / Q000706:statistics & numerical data; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D020280:Sertraline / Q000191:economics* / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D000928:Antidepressive Agents; D010919:Placebos; D008803:Mianserin; D000078785:Mirtazapine; D020280:Sertraline