The use of antidepressants in dementia patients should be reconsidered, a Government advisor has recommended, after his study found two of the most commonly prescribed treatments were no more effective then placebo and caused more side effects.
Expert researchers in Alzheimer's disease and dementia conducted a randomised controlled trial in 325 patients with probable or possible Alzheimer's disease prescribed with steraline or mirtazapine, which the researchers argued are ‘the two classes of antidepressants most likely to be prescribed for depression in Alzheimer's disease', compared with placebo.
Some 107 patients were assigned to receive sertraline 150mg per day, while 107 patients were prescribed mirtazapine 45mg daily and 111 patients were given a placebo. All patients also received standard care. The primary outcome was reduction in depression at 13 weeks.
The severity of depression, as measured by the Cornell scale for depression in dementia, decreased in all three intervention groups compared with baseline, but at 13 weeks depression scores did not differ significantly between the 111 controls (in whom the adjusted reduction in depression scores was 4.1) and the scores for patients on sertraline and mirtazapine (which were 4.9 and 5.0, respectively).
But there was no significant difference in the level of reduction in depression scores in both groups compared with placebo, with a mean difference on 1.17 seen in patients on sertraline and 0.01 in patients on mirtazapine.
But significantly, more patients on antidepressants – more than 40% - had adverse reactions and ‘serious adverse events rated as severe', compared with 26% of controls.
The study, published today online in The Lancet, came as new figures published by the Office for National Statistics showed that between 1991 and 2009 prescriptions dispensed for antidepressants increased by 334% in England.
Study leader Professor Sube Banerjee, the Department of Health advisor and author of the National Dementia Strategy, said the trial had important clinical implications, and ‘implies a need to change the present clinical practice of prescription of antidepressants as the first-line treatment of depression in dementia caused by Alzheimer's disease.'
Professor Banerjee, professor of mental health and ageing at South London Maudsley NHS Foundation trust, concluded: ‘The practical implications of this study are that we should reframe the way we think about the treatment of people with dementia who are depressed, and reconsider the routine prescription of antidepressants.'
'When potential cases are recognised, patients should be referred to local specialist services. On the basis of our data, the use of antidepressants might be reserved for individuals whose depression has not resolved within three months of referral, apart from those in whom drug treatment is indicated by risk or extreme severity.'
The Lancet 2011, online 19 July