Around 430 people over 75 who have recovered from depression will be randomly assigned to either stay on their antidepressant or switch to a placebo, to see whether continuing the drugs actually prevents relapse. This matters because doctors lack clear evidence on whether long-term antidepressant use benefits the oldest patients. People over 75 are often prescribed these drugs for years, yet the drugs carry side effects—dizziness, falls, interactions with other medications—that can be especially harmful in this age group. The trial directly tests whether the protective effect against relapse outweighs those risks. If the research shows that stopping antidepressants after recovery is safe and effective, it could change prescribing guidelines for older adults. Many patients might taper off unnecessary medication, reducing polypharmacy and its complications. If continuing is clearly better, doctors will have stronger justification for long-term prescribing. Either way, the trial gives GPs and patients concrete data to make informed decisions about a common but poorly understood treatment scenario.
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Research question: Should older adults (aged >75) continue to take antidepressants for a further 12 months after recovery from depression? Background: Antidepressants are commonly prescribed to older people for long periods, have significant side-effects and contribute to polypharmacy. Risks and benefits of continued treatment once depression has remitted are unclear, particularly effects on preventing depression relapse. Aims and objectives: The aim is to investigate the effectiveness and cost-effectiveness of continuing an antidepressant for 12 months in preventing depression relapse in people over 75 and who have recovered from depression after treatment in primary care, by comparing maintenance antidepressants with discontinuation following a taper. Objectives are (1) To estimate the difference in time to depressive episode between maintenance and discontinuation randomised groups; (2) To estimate the difference in depression and anxiety symptoms between randomised groups; (3) To determine the difference in antidepressant withdrawal symptoms between randomised groups. (4) To estimate the difference in health-related quality of life between randomised groups. (5) To compare the relative cost-effectiveness of the two arms of the trial. (5) To provide data on older people’s experiences of reducing and stopping antidepressants and the nature, incidence and duration of withdrawal symptoms. Methods: Multicentre parallel group double-blind 1:1 individually randomised placebo-controlled clinical trial with an internal pilot. 430 participants recruited from 300 general practices in London, Bristol, Manchester, Oxford, Newcastle and York, aged 75 or older, with history of two or more episodes of depression or taking antidepressants (citalopram, mirtazapine or sertraline) for at least two years. Exclusions will be currently depressed, bipolar disorder or dementia diagnosis (although people with mild cognitive impairment will be eligible). The intervention is 12 months’ discontinuation to take identical placebo after tapering and the comparator is remaining on citalopram 20mg, sertraline 50mg or mirtazapine 30mg. Participants will be randomised 1:1 to continue with their prescribed antidepressant (maintenance group) or to taper and discontinue treatment (discontinuation group), with site, medication and baseline Geriatric Depression Scale score as minimisation factors. The primary outcome is first relapse of depression in time-to-event analysis during 52 weeks of follow-up assessed with an adapted Clinical Interview Schedule–Revised Version to assess symptoms over the previous 8 weeks. Secondary outcomes are symptoms of depression, symptoms of anxiety, physical symptom side-effects of antidepressants, antidepressant withdrawal effects, cognitive functioning, fitness-frailty, polypharmacy, multimorbidity, health and social care resource use and health-related quality of life for economic evaluation. Timelines for delivery: This is a 48-month trial. Start on 1 July 2023 and Months 1-9 trial set-up, REC/MHRA approvals, IMP purchase and packaging, identification and preparation of recruiting practices; Months 10-30 participant recruitment; Months 31-42 completion of follow-up and outcomes collection; Months 43-48 data analysis, publication and Report preparation. Anticipated impact and dissemination: Publication of main outcomes in high impact/HTA medical journals, conference presentations. Inclusion in Cochrane reviews and NICE Guidelines.
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