DeprescribingGPS-ADNCT07398053
General Practitioner & Pharmacist Support for Discontinuing Long-term Antidepressants in Clinically Stable Patients
A study testing GPS-AD intervention in people with Deprescribing and Antidepressant, run by University Ghent.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deprescribing, Antidepressant, Depression Disorder
- What is being tested?
- GPS-AD intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lies Vanderbeken contact
About this study
Official title: General Practitioner & Pharmacist Support for Discontinuing Long-term Antidepressants in Clinically Stable Patients: a Cluster Randomised Pragmatic Trial in Primary Care
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.
Read more
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.
- Being tested
- GPS-AD intervention
- Keywords
- deprescribing, discontinuation, tapering, depression, antidepressants, long-term use, chronic use, medication review, primary care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPS-AD interventionBehavioural
Also called AD discontinuation, AD deprescribing
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 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.
| Study group | Role | What they receive |
|---|---|---|
| GPS-AD intervention | Experimental | 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. Receives: Behavioral: GPS-AD intervention |
| care as usual | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months post-randomisation
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.
Measured: 12 months post-randomisation
Secondary outcomes (5)
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.
Measured: 6, 18 and 24 months post-randomisation
Depressive symptom severity
PHQ-9 total score
Measured: 6, 18 and 24 months post-randomisation
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.
Measured: 6, 12, 18, and 24 months
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
Measured: 6, 12, 18 and 24 months
Mental wellbeing
Mental wellbeing assessed using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), with higher total scores indicating better mental wellbeing.
Measured: 6, 12, 18, and 24 months post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeprescribingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic cluster-randomized trial in Belgian primary care. General practitioner (GP) practices are the unit of randomization (cluster) to minimize contamination; patients are the unit of analysis.
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege, Université Catholique de Louvain, Université Libre de Bruxelles, KU Leuven, Universiteit Antwerpen, VUB
- Responsible party
- Sponsor
- Investigators
- Ellen Van Leeuwen, MD, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398053
- Sponsor's protocol ID
- ONZ-2025-0571
- Other IDs
- KCE-24 1543
- Acronym
- GPS-AD
- Status last verified
- Feb 2026
- First submitted
- 24 Dec 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Practitioner & Pharmacist Support for Discontinuing Long-term Antidepressants in Clinically Stable Patients: a Cluster Randomised Pragmatic Trial in Primary Care
- ClinicalTrials.gov ID
- NCT07398053
- Acronym / sponsor ID
- GPS-AD / ONZ-2025-0571
- Keywords
- deprescribing, discontinuation, tapering, depression, antidepressants, long-term use, chronic use, medication review
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University of Liege, Université Catholique de Louvain, Université Libre de Bruxelles, KU Leuven, Universiteit Antwerpen, VUB
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic cluster-randomized trial in Belgian primary care. General practitioner (GP) practices are the unit of randomization (cluster) to minimize contamination; patients are the unit of analysis.
| Arm | Type | Receives |
|---|---|---|
| GPS-AD intervention | Experimental | Behavioral: GPS-AD interventionThe 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. |
| care as usual | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Are judged by their GP as no longer meeting the criteria for a current depressive disorder.
Key exclusion criteria (13 listed)
- 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:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPS-AD interventionAlso: AD discontinuation, AD deprescribingThe 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. | Behavioural | GPS-AD intervention |
Primary outcome
AD discontinuation (superiority)
Time frame: 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)
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Trial page created by funder: KCE TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lies Vanderbeken contact
Ellen Van Leeuwen, MD, PhD principal investigator
University Ghent
Questions about this trial
What is this clinical trial studying?
A study testing GPS-AD intervention in people with Deprescribing and Antidepressant, run by University Ghent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen Van Leeuwen, MD, PhD (+32 (0) 498 66 60 30, ellen.vanleeuwen@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AD discontinuation (superiority) (time frame: 12 months post-randomisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.