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Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial

Banerjee, Sube, Hellier, Jennifer, Dewey, Michael, Romeo, Renee, Ballard, Clive, Baldwin, Robert, Bentham, Peter, Fox, Chris, Holmes, Clive, Katona, Cornelius, Knapp, Martin, Lawton, Claire, Lindesay, James, Livingston, Gill, McCrae, Niall, Moniz-Cook, Esme, Murray, Joanna, Nurock, Shirley, Orrell, Martin, O'Brien, John, Poppe, Michaela, Thomas, Alan, Walwyn, Rebecca, Wilson, Kenneth and Burns, Alistair (2011) Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial The Lancet, 378, (9789), pp. 403-411. (doi:10.1016/S0140-6736(11)60830-1). (PMID:21764118).

Record type: Article

Abstract

Background. Depression is common in dementia but the evidence base for appropriate drug treatment is sparse and equivocal. We aimed to assess efficacy and safety of two of the most commonly prescribed drugs, sertraline and mirtazapine, compared with placebo.

Methods. We undertook the parallel-group, double-blind, placebo-controlled, Health Technology Assessment Study of the Use of Antidepressants for Depression in Dementia (HTA-SADD) trial in participants from old-age psychiatry services in nine centres in England. Participants were eligible if they had probable or possible Alzheimer's disease, depression (lasting ?4 weeks), and a Cornell scale for depression in dementia (CSDD) score of 8 or more. Participants were ineligible if they were clinically critical (eg, suicide risk), contraindicated to study drugs, on antidepressants, in another trial, or had no carer. The clinical trials unit at King's College London (UK) randomly allocated participants with a computer-generated block randomisation sequence, stratified by centre, with varying block sizes, in a 1:1:1 ratio to receive sertraline (target dose 150 mg per day), mirtazapine (45 mg), or placebo (control group), all with standard care. The primary outcome was reduction in depression (CSDD score) at 13 weeks (outcomes to 39 weeks were also assessed), assessed with a mixed linear-regression model adjusted for baseline CSDD, time, and treatment centre. This study is registered, number ISRCTN88882979 and EudraCT 2006-000105-38.

Findings. Decreases in depression scores at 13 weeks did not differ between 111 controls and 107 participants allocated to receive sertraline (mean difference 1·17, 95% CI ?0·23 to 2·58; p=0·10) or mirtazapine (0·01, ?1·37 to 1·38; p=0·99), or between participants in the mirtazapine and sertraline groups (1·16, ?0·25 to 2·57; p=0·11); these findings persisted to 39 weeks. Fewer controls had adverse reactions (29 of 111 [26%]) than did participants in the sertraline group (46 of 107, 43%; p=0·010) or mirtazapine group (44 of 108, 41%; p=0·031), and fewer serious adverse events rated as severe (p=0·003). Five patients in every group died by week 39.

Interpretation. Because of the absence of benefit compared with placebo and increased risk of adverse events, the present practice of use of these antidepressants, with usual care, for first-line treatment of depression in Alzheimer's disease should be reconsidered.

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More information

e-pub ahead of print date: 18 July 2011
Published date: 30 July 2011
Organisations: Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 337605
URI: http://eprints.soton.ac.uk/id/eprint/337605
ISSN: 0140-6736
PURE UUID: cb3698c9-44b1-46da-b327-bb233e5a4a44

Catalogue record

Date deposited: 01 May 2012 09:27
Last modified: 18 Jul 2017 06:02

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Contributors

Author: Sube Banerjee
Author: Jennifer Hellier
Author: Michael Dewey
Author: Renee Romeo
Author: Clive Ballard
Author: Robert Baldwin
Author: Peter Bentham
Author: Chris Fox
Author: Clive Holmes
Author: Cornelius Katona
Author: Martin Knapp
Author: Claire Lawton
Author: James Lindesay
Author: Gill Livingston
Author: Niall McCrae
Author: Esme Moniz-Cook
Author: Joanna Murray
Author: Shirley Nurock
Author: Martin Orrell
Author: John O'Brien
Author: Michaela Poppe
Author: Alan Thomas
Author: Rebecca Walwyn
Author: Kenneth Wilson
Author: Alistair Burns

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