Optimization of Deprescribing Antidepressants in Nursing Home Residents With Dementia (NCT04985305) | Clinical Trial Compass
CompletedNot Applicable
Optimization of Deprescribing Antidepressants in Nursing Home Residents With Dementia
Denmark180 participantsStarted 2021-10-15
Plain-language summary
The effectiveness of psychotropic medication on behavioral and psychological symptoms in dementia (BPDS) is limited, while they are associated with a higher risk of morbidity and mortality. Non-pharmacological treatment of BPSD is advocated as treatment of first choice. However, many general practitioners (GPs) find it difficult to initiate deprescribing and when attempting to discontinue psychotropic drugs in nursing home residents, they can face substantial barriers both among nursing home staff and relatives. Therefore, the investigators have developed an intervention specifically aimed at increasing knowledge on deprescribing and improving communication and collaboration between GPs, nursing home staff, relatives and patients to optimize the pharmacological treatment of BPSD.
Who can participate
Age range
72 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥72 years old
* Either have a diagnosis of dementia or have a severe cognitive impairment as judged by the GP
* Are permanently living at the nursing home
* Are prescribed at least one antidepressant with the following ATC-codes
* Selective serotonin reuptake inhibitors (SSRIs): N06AB10 (Escitalopram); N06AB04 (Citalopram); N06AB08 (Fluvoxamin); N06AB03 (Fluoxetin); N06AB05 (Paroxetin); N06AB06 (Sertralin);
* Serotonin-Norepinephrine Reuptake inhibitors (SNRIs): N06AX21 (Duloxetin); N06AX16 (Venlafaxin);
* Tricyclic antidepressants (TCAs): N06AA09 (Amitriptylin); N06AA04 (Clomipramin); N06AA02 (Imipramin); N06AA10 (Nortriptylin); (Dosulepin); N06AA17
* Noradrenergic and specific serotonergic antidepressants (NaSSAs) / Atypical antidepressants N06AX03 (Mianserin); N06AX11 (Mirtazapin);
* Monoamine oxidase inhibitors (MAOIs):N06AF01 (Isocarboxazid);
* Noradrenaline reuptake inhibitor (NARI): N06AX18 (Reboxetin);
* Other antidepressant with effect on the serotonin-system: N06AX26 (Vortioxetin);
* Melatonin agonists: N06AX22 (Agomelatin);
Exclusion Criteria:
* They are under treatment of a psychiatrist.
* They are enrolled in another psychopharmacological trial
* There is a suspicion of a current clinical, major depression or suicidal behavior and intentions.
* Receiving end-of-life care
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction of antidepressant
Timeframe: Intervention period of three months for each patient.