General Practitioner & Pharmacist Support for Discontinuing Long-term Antidepressants in Clinically Stable Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Ghent
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are 18 years or older and capable of providing informed consent.
Have their Global Medical File (GMD) managed by one of the participating GPs.
at least 6 months of continuous daily use following a first depressive episode, or
at least 2 years of continuous daily use in the context of a relapsed depression/recurrent episode
Disqualifiers
AD discontinuation is considered contra-indicated by the treating GP.
Current significant depressive symptoms, defined as a score of ≥12 on the PHQ-9
Current significant anxiety symptoms, defined as a score of ≥10 on the Generalised Anxiety Disorder-7 (GAD-7) scale.
Current suicidal ideation, defined as a score >0 on item 9 (suicidality) of the PHQ-9.
Trial design
Design model
Parallel
Treatments tested in this trial
GPS-AD intervention
BehavioralThe GPS-AD intervention is a structured collaboration between GPs and community pharmacists designed to support the safe discontinuation of long-term AD use in clinically stable adults. The intervention incorporates behavioural activation, motivational support, shared decision-making, personalised tapering schedules, and collaborative care. It follows a stepped-care model and clearly defines the roles of both the GP and pharmacist. It starts with an invitation letter and educational brochure that encourages patients to book an appointment with their GP to review their AD use. This is followed by at least one consultation with the GP to discuss the option of tapering AD. If the patient is ready, a personalised tapering plan will be started in collaboration with the pharmacist. The pharmacist provides an initiation consultation, including medication review, tapering plan, potential withdrawal symptoms, motivational support, and a closing consultation focused on future coping.
Treatment groups
324 Participants
are divided into 2 treatment groupsGroup A: GPS-AD interventionExperimental treatment 1 intervention
Group B: care as usualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
AD discontinuation (superiority)
Proportion of participants who have stopped antidepressant medication for ≥2 consecutive months at the 12-month follow-up assessment, based on participant self-report. This is a binary measure (yes/no).
Time frame
12 months post-randomisation2
Depressive symptom severity (inferiority)
PHQ-9 total score (range 0-27; higher scores indicate more severe depressive symptoms) at 12 months post-randomisation; this is a continuous metric. Difference in baseline-corrected mean between groups will be evaluated, with 95% CI. Non-inferiority will be assessed using a prespecified non-inferiority margin of 2 points. In this trial, we use co-primary endpoints. The trial will conclude effectiveness only if (1) discontinuation is superior and (2) PHQ-9 is non-inferior.
Time frame
12 months post-randomisationSecondary outcomes
1
AD discontinuation
Proportion of participants who have stopped antidepressant medication for ≥2 consecutive months at the 6-month follow-up assessment, based on participant self-report. This is a binary measure (yes/no) at 6, i.e. short-term, 18 and 24, i.e. long-term, months.
Time frame
6, 18 and 24 months post-randomisation2
Depressive symptom severity
PHQ-9 total score
Time frame
6, 18 and 24 months post-randomisation3
Suicidal ideation
Patient-reported suicidal ideation assessed using item 9 of the Patient Health Questionnaire-9 (PHQ-9), scored 0-3, with higher scores indicating more frequent suicidal thoughts.
Time frame
6, 12, 18, and 24 months4
Health-related quality of life
Health-related quality of life measured using the EQ-5D-5L questionnaire, summarized as a country-specific index value derived from the five dimensions
Time frame
6, 12, 18 and 24 monthsOther outcomes
1
Safety: adverse effects of AD
Patient-reported adverse effects of antidepressants assessed using the Antidepressant Side-Effect Checklist (ASEC). The ASEC includes 21 predefined side effects
Time frame
6, 12, 18, 24 months post-randomisation2
Safety: relapse or new depressive episode
Occurrence of relapse or new depressive episode during the preceding 6 months, assessed by the GP based on clinical evaluation and electronic health record review (Yes/No).
Time frame
6, 12, 18 and 24 months post-randomisation3
Safety: withdrawal symptoms
Patient-reported antidepressant withdrawal symptoms assessed using an abbreviated version of the Discontinuation Emergent Signs and Symptoms (DESS) questionnaire.
Time frame
6 and 12 months4
Safety: clinician-assessed withdrawal symptoms
GP-reported occurrence of antidepressant withdrawal symptoms during the preceding 6 months, based on clinical evaluation and electronic health record review (Yes/No).
Time frame
6 and 12 months post-randomisationLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Ghent
Lead sponsor
University of Liege
Collaborator
Université Catholique de Louvain
Collaborator
Université Libre de Bruxelles
Collaborator
KU Leuven
Collaborator
Universiteit Antwerpen
Collaborator
VUB
Collaborator
Source ClinicalTrials.gov
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