The WiserAD Trial: Protocol for the Pragmatic, Randomised Controlled Trial of a Structured Online Support Intervention to Inform and Assist Antidepressant Deprescribing in Primary Care. (Preprint)

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BACKGROUND The use of antidepressant medications is increasing globally. However, despite their obvious benefits, there is reason to believe that ongoing use of these medications is often not properly monitored or deprescribed when a person returns to better mental health; in addition, the proportion of prescriptions written to those who do not suffer from a clinical depression, lead to a personal and societal cost burden. OBJECTIVE This paper describes the protocol of a stratified single blind, parallel two-arm, individually randomised controlled trial to assess the clinical and cost effectiveness of an online support tool to help patients with mild to no symptoms of depression and their general practitioners manage the careful and appropriate tapering and cessation of antidepressants at 6 months in primary care compared to attention control. METHODS General practice patients with mild to no symptoms of depression, and who have been taking antidepressant medication for longer than 12 months. After informed consent, 340 eligible patients will be randomised 1:1 into either the active intervention arm, where they will be asked to reduce their antidepressant with the aid of a clinically guided online support tool, or the attention control arm, that will continue with usual care. Participants in both arms will be provided with information about antidepressants through the Beyond Blue website and will be followed up at 3, 6 ,12 and 18 months to record antidepressant use, depression and anxiety symptom severity, and quality of life. Health economic information will also be collected. Intention to treat analysis will determine the clinical effectiveness of the online tool compared to attention control, where the primary outcome is between-arm difference in the proportion of participants with successful cessation of medication at 6 months with depression remaining mild or absent. Cost-consequence and cost-utility analyses will be used to determine the cost effectiveness of the intervention and its impact on quality of life, compared to usual care. RESULTS As of 25th July 2025, 310 participants had been randomised into the study and recruitment is ongoing CONCLUSIONS This world first trial of an online support tool to assist patients and their GP with deprescribing may lead to successful cessation of antidepressant medication, resulting in an enhanced quality of life and cost savings over the longer term. CLINICALTRIAL ANZCTR: ACTRN12622000567729. ISRCTN: 11562922. ClinicalTrials: NCT05355025

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