Two antidepressants prescribed often for individuals with Alzheimer’s disease – sertraline or mirtazapine – were found to have no benefits for such patients. In fact, they also experienced unpleasant side effects., according to the results of the HTA-SADD trial published in The Lancet. The article was written by Professor Sube Banerjee and team, Institute of Psychiatry, King’s College London, UK.
The trial involved 325 patients from nine different centers in England. They all had either possible Alzheimer’s disease, depression which had lasted at least 4 weeks, or a dementia-related depression above a certain score. Any patient who was a suicide risk, contraindicated for the drugs, was already on antidepressants, or was at the time already taking part in another trial, was ineligible for this study.
They were randomly selected into one of three groups:
- Sertraline group – 150mg per day – 107 patients
- Mirtazapine group – 45 mg per day – 107 patients
- Control group – placebo – 111 patients
The researchers were focusing (primary outcome) on how much depression might be reduced after 13 weeks of treatment. They all also received standard care.
At 13 weeks there were no differences in the depression scores among the three groups, not even at 39 weeks.
26% of those on the placebo group experienced adverse reactions, compared to 43% in the sertraline group and 41% in the mirtazapine group. By week 39 five participants had died in each group.
The researchers concluded:
“The two classes of antidepressants most likely to be prescribed for depression in Alzheimer’s disease are no more effective than placebo. In our study, there were more adverse reactions in individuals treated with antidepressants than there were with placebo. Clinicians and investigators need to reframe the way they think about the treatment of people with Alzheimer’s disease who are depressed, and reconsider routine prescription of antidepressants.”
Dr Henry Brodaty, Brain and Ageing Research Program and Primary Dementia Collaborative Research Centre, University of New South Wales, Sydney, Australia, concluded in a Comment in the same journal:
“The HTA-SADD trial has underscored the need for clinicians to think about creative alternatives to drug treatment for management of depression in people with dementia, and to use evidence-based techniques and partnerships with family carers.”
Prof Sube Banerjee MD, Jennifer Hellier MSc, Michael Dewey PhD, Renee Romeo PhD, Clive Ballard MD, Robert Baldwin MD, Peter Bentham MRCPsych, Chris Fox MD, Clive Holmes PhD, Cornelius Katona MD, Martin Knapp PhD, Claire Lawton FRCPsych, James Lindesay DM, Gill Livingston MD, Niall McCrae PhD, Esme Moniz-Cook PhD, Joanna Murray MA, Shirley Nurock MSc, Martin Orrell PhD, John O’Brien DM, Michaela Poppe PhD, Alan Thomas PhD, Rebecca Walwyn PhD, Kenneth Wilson MD, Alistair Burns MD
The Lancet, Early Online Publication, 18 July 2011 doi:10.1016/S0140-6736(11)60830-1
Written by Christian Nordqvist