Authors' objectives: There were over 53m prescriptions of antidepressants issued in primary care in England in 2013 and many of these were for repeat prescriptions. Antidepressants are used both for treating the acute episode and also for preventing future episodes of depression, also called maintenance treatment. There is good evidence that maintenance treatment that lasts 9 months is effective. However, there is still uncertainty about long term maintenance treatment. The NICE guidelines recommend that some people at risk of relapse should stay on maintenance antidepressants for 2 years but as the guideline group recognised themselves there is currently no evidence to support this policy. Surveys of the general population and in general practice indicate that there are large numbers of patients taking antidepressants in the UK, somewhere between 5% and 8% and up to half of these will be taking them long term and half of those will have relatively few symptoms. There are therefore a substantial proportion of people taking long term maintenance antidepressant treatment even though there is little evidence for its effectiveness. The proposed study will investigate the effectiveness of long term maintenance treatment in UK primary care. The participants will be people who have been treated for depression, who are now taking long term (more than 9 months) maintenance antidepressants and now feel well enough to consider stopping medication. RESEARCH QUESTION What is the clinical and cost-effectiveness in UK primary care of continuing on long term maintenance antidepressants compared to a placebo in preventing relapse of depression in those who have taken antidepressants for more than 9 months and who are now well enough to consider stopping maintenance treatment? We propose to identify people in primary care who are on long term antidepressant medication by asking general practitioners to search their electronic patient records. We will include people taking four antidepressants (citalopram, sertraline, fluoxetine and mirtazapine) that between them comprise 75% of all antidepressant prescriptions. We will carry out a randomised controlled trial that will compare long term maintenance antidepressants with an identical placebo. We will make sure that the people who are withdrawn from antidepressants have a more gradual reduction in dose to avoid withdrawal symptoms. We will follow up participants for 12 months as previous research has indicated that the increase in relapse rate following withdrawal of maintenance medication occurs within 6 months of medication withdrawal.

Project Status: Ongoing

URL for project: http://www.nets.nihr.ac.uk/projects/hta/1311548

Anticipated Publish Date: 2021

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

Copyright: Queen's Printer and Controller of HMSO