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O2‐05‐04: HTA‐SADD a definative multicentre placebo controlled RCT of the clinical effectiveness of sertraline and mirtazapine for the treatment of depression in dementia
Author(s) -
Banerjee Sube
Publication year - 2011
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2011.05.869
Subject(s) - sertraline , placebo , dementia , depression (economics) , randomized controlled trial , medicine , psychiatry , clinical trial , psychology , physical therapy , antidepressant , anxiety , alternative medicine , disease , macroeconomics , pathology , economics
Background: Depression is a common and important comorbidity in dementia. Occurring in up to 20% of cases, it causes additional distress and decrease in quality of life. There is uncertainty about the clinical effectiveness of anti-depressants in depression in dementia. The current Cochrane review is equivocal but clinical practice favors antidepressants with sertraline commonly used because of positive findings in the DIADS study. Clinical choice has been brought into doubt by the negative findings of DIADS-2 which found no positive effect for sertraline. This study was designed to generate a definitive answer to the question of whether antidepressants have a positive role in treating depression in dementia. We completed a multi-center, double-blind, placebo-controlled RCT of the clinical and cost effectiveness of mirtazipine and sertraline, from baseline to 13 and 39 weeks. Patients were recruited from old age psychiatric services in 9 UK sites. Primary outcomes were Cornell Scale for Depression in Dementia (CSDD) and cost. Primary analysis was CSDD score at 13 and 39 weeks by ANCOVA adjusted for baseline CSDD and center contrasting for sertraline vs. Placebo and mirtazipine vs. Placebo. Results: Here we present data from preliminary analyses. 326 subjects were recruited, 111 were randomised to placebo, 107 to sertraline and 108 to mirtazipine. Average age was 79 years; 68% were female. The mean MMSE score was 18 and the average CSDD 13. Raw change from baseline at week 13 for sertraline was -3.9 (sd 5.1); mirtazipine -5.0 (4.9); and placebo -5.6 (4.7). At week 39 the changes from baseline were: sertraline -4.0 (5.2); mirtazipine -4.0 (5.2); and placebo -4.8 (5.5). Multivariate analyses showed no superiority for either antidepressant over placebo. Conclusions: These data suggest that sertraline and mirtazipine may be ineffective treatments for depression in dementia relative to placebo. It is striking that the placebo group has as positive as outcome as it does. This may point to the value of the non-pharmacological elements of treatment provided by mental health services which are independent of medication offered. These data, while preliminary, suggest that the use of antidepressants as a first line treatment for depression in dementia should be questioned.