Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT04985305
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
72 Years
Study:
NCT04985305
Study Brief:
Protocol Section:
NCT04985305