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:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT04618250
Eligibility Criteria:
Inclusion Criteria:
* Registered at a general practice situated in the Danish Capital Region or the Region of Zealand;
* Registered at general practice with International Classification of Primary Care version 2 (ICPC-2) diagnostic code p72 (psychotic disorders);
* Registered at general practice with ICPC-2 diagnostic code p73 (bipolar mood disorders);
* Prescription of Lithium (Anatomical Therapeutic Chemical (ATC): N05AN);
* Registered at general practice with ICPC-2 diagnostic code p76 AND (Prescription of Lamotrigine (N03A09) OR Carbamazepine (N03AF01) OR Valproic Acid (N03AG01));
* Registered at general practice with ICPC-2 diagnostic code p76 (unipolar depressive disorders) AND (Prescription of tricyclic antidepressants (N06AA) AND/OR venlafaxine (N06AX16) AND/OR duloxetine (N06AX21) AND/OR Monoamine Oxidase A Inhibitor (MAOi) (N06AG) AND/OR non-selective MAOi (N06AF)).
Exclusion Criteria:
* Subjected to any type of legal measure as stipulated in the Danish Mental Health Law;
* Registered with a dementia diagnosis ICPC-2 p70 (dementia);
* Receiving end-of-life care;
* Non-Danish speakers;
* Assumed by the patient's general practitioner to have an overall functional level that is too low for meaningful participation in trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04618250
Study Brief:
Protocol Section:
NCT04618250