In Belgium, many adults who have suffered from depression keep using antidepressants on a daily basis for years afterwards, sometimes longer than guidelines recommend. Yet for some people who have been feeling well for a long time, this is no longer necessary, while the continued use of antidepressants can lead to side effects and causes additional costs for the healthcare system.
However, reducing the doses of antidepressants or stopping altogether is not always easy. Some patients are afraid that their depression will return, and GPs and pharmacists often find the subject difficult to broach.
This is why the GPS-AD study is investigating a new approach in which GPs and pharmacists work more closely together to provide better support to patients. First, the GP invites patients who have been taking antidepressants for a long time for a consultation. Together, they discuss whether tapering of the medication is reasonable and feasible. If they agree to stop the treatment, the GP draws up a tapering plan tailored to the patient. The pharmacist helps monitor this process, offering advice and support to the patient while the doses are gradually reduced.
The study will extend over a period of two years and will take place in GP practices throughout Belgium. The new approach based on closer collaboration between GPs and pharmacists will be compared to the current standard of care, to determine whether it helps more long-term users to stop taking antidepressants without experiencing a recurrence of depressive symptoms.
The name of the study, GPS-AD (General Practitioner and Pharmacist Support for Antidepressant Discontinuation), refers to the collaboration between GPs and pharmacists in tapering of antidepressants, and also symbolises the support and guidance (the ‘GPS’) provided to patients and healthcare providers in assessing whether long-term use of antidepressants is still necessary.
| Title | General practitioner & pharmacist support for discontinuing long-term antidepressants in clinically stable patients: a cluster randomised pragmatic trial in primary care. |
| Participants (P) | Adults taking any type of antidepressant prescribed for a primary diagnosis of depressive disorder. Eligible patients have used an antidepressant for at least 6 months (after a first episode of depression) or 2 years (for those at higher relapse risk). |
| Intervention (I) | A structured, stepped-care approach including: • Patient invitation: all eligible patients with long-term antidepressant use in the participating GP practice will receive a review letter and an educational brochure, inviting them to schedule a consultation with their GP to review and discuss their AD use. • If patients are interested, they will be invited to make an appointment with their GP • First GP consultation: the GP reviews patient’s antidepressant use, assesses motivation and readiness to discontinue, provides information about tapering, and motivates the patient to consider discontinuing. o A second GP consultation, if required, (1 to 3 weeks later) The GP creates a personalised tapering plan together with the patient. Both sign an antidepressant tapering agreement. The agreement will also include information explaining the pharmacist’s role. • Two pharmacist consultations: The pharmacist supports and motivates the patient through 2 consultations during the tapering period (one at the start and 1 at the end of tapering). All further follow-up during the tapering process will be provided as needed by the GP and the pharmacist, following usual care. |
| Control (C) | Patients will be supported according to standard care |
| Outcome (O) | 2 co-primary outcomes (measured at 12 months after randomisation): • Discontinuation of antidepressants at 12 months for ≥ 2 months, pt self-reported and prescription check by GP (superiority design) • Occurrence of depressive symptoms, measured by the 9-item Patient Health Questionnaire (PHQ-9) (non-inferiority design) Effectiveness will be concluded only if both endpoints are successfully demonstrated. |
| Trial Design | Cluster-randomised pragmatic trial in primary care settings in Belgium. Randomisation clustered by participating GP practices |
| Sample Size | 324 participants randomised by 60 GP practices |
| Trial duration | 21 months for main study (33 months inc. LTFU) |
| Budget | 1,140,000 € |
| Sponsor | U Gent |
| Chief Investigator | Dr Ellen Van Leeuwen, MD, PhD |
| External partners | Academic centres of general practice: Department of Public Health and Primary Care, Ghent University Department of Public Health and Primary Care, KULeuven Department of Family Medicine and Population Health, Faculty of Medicine and Health Sciences, University of Antwerp Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel Department of General Practice, Université de Liège Department of General Medicine, Université Libre de Bruxelles Centre Académique de Médecine Générale, UCLouvain |
| Number of participating sites | 60 GP practices/ medical centres |
