General Practitioner & Pharmacist Support for Discontinuing Long-term Antidepressants in Clinically Stable Patients

Official title

General Practitioner & Pharmacist Support for Discontinuing Long-term Antidepressants in Clinically Stable Patients: a Cluster Randomised Pragmatic Trial in Primary Care

Overview

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.

Interventions

• Behavioral GPS-AD intervention
  The 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 th

Primary outcome measures

• AD discontinuation (superiority) [Time frame: 12 months post-randomisation]
• Depressive symptom severity (inferiority) [Time frame: 12 months post-randomisation]

Secondary outcome measures (5)

• AD discontinuation [Time frame: 6, 18 and 24 months post-randomisation]
• Depressive symptom severity [Time frame: 6, 18 and 24 months post-randomisation]
• Suicidal ideation [Time frame: 6, 12, 18, and 24 months]
• Health-related quality of life [Time frame: 6, 12, 18 and 24 months]
• Mental wellbeing [Time frame: 6, 12, 18, and 24 months post-randomisation]

Eligibility criteria

Inclusion criteria

Patients will be eligible for inclusion in the study if they meet all of the following criteria:

• Are 18 years or older and capable of providing informed consent.
• Have their Global Medical File (GMD) managed by one of the participating GPs.
• Have been prescribed AD (any type) by their GP for the treatment of depression, with:

• 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
• Are judged by their GP as no longer meeting the criteria for a current depressive disorder.

Exclusion criteria

Patients will be excluded from participation in the study if they meet any of the following criteria:

• AD discontinuation is considered contra-indicated by the treating GP.
• The patient is judged by the GP to be at high risk of relapse. This includes any of the following:

• 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.
• The patient is currently receiving only psychiatric treatment (out- or inpatient) for depression

In addition to the criteria increasing the risk of relapse, the following will also be an exclusion criteria:

• The patient has a current psychiatric comorbidity (e.g. bipolar disorder, psychosis, substance use)
• The patient has a diagnosis of dementia or significant cognitive impairment (assessed by GP judgement) or is living in a nursing home.
• The AD is prescribed for a primary indication other than depression, such as anxiety alone without comorbid depressive disorder, or chronic pain.
• The patient has insufficient language proficiency in Dutch or French to participate in the study procedures (e.g. providing consent, completion of questionnaires, interviews).
• use of trazodon as AD as this is mainly used for sleep problems

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07398053 · ONZ-2025-0571 · KCE-24 1543

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗