General Practitioner & Pharmacist Support for Discontinuing Long-term Antidepressants in Clinically Stable Patients: a Cluster Randomised Pragmatic Trial in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 324
- 主要终点
- AD discontinuation (superiority)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the intervention, participants/clinicians are not blinded. Outcome assessors and statisticians will remain blinded to group allocation until all analyses are complete.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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-
- •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
研究组 & 干预措施
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.
干预措施: GPS-AD intervention (Behavioral)
care as usual
The management and follow-up in the usual care arm is at the discretion of GP/pharmacist/patient, following the Belgian depression guideline. Patients in the control group will receive care as usual.
结局指标
主要结局
AD discontinuation (superiority)
时间窗: 12 months post-randomisation
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).
Depressive symptom severity (inferiority)
时间窗: 12 months post-randomisation
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.
次要结局
- AD discontinuation(6, 18 and 24 months post-randomisation)
- Depressive symptom severity(6, 18 and 24 months post-randomisation)
- Suicidal ideation(6, 12, 18, and 24 months)
- Health-related quality of life(6, 12, 18 and 24 months)
- Mental wellbeing(6, 12, 18, and 24 months post-randomisation)