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 @ 5:22 PM
Ignite Modification Date:
2025-12-24 @ 5:22 PM
NCT ID:
NCT04035850
Eligibility Criteria:
Inclusion Criteria:
1. a principal DSM-5 diagnosis of HD
2. SI-R score\>=40
3. age between 25-65
4. no other antidepressant use in the 4 weeks that precede the first Vortioxetine dose\*
5. ability to provide written informed consent
* Patients on non-Vortioxetine antidepressant who are willing to participate in the study and meet all other inclusion and exclusion criteria will be offered a 4-week antidepressant wash out period.
Exclusion Criteria:
1. current or past diagnosis of mania/hypo-mania, psychotic disorder or a 1st-degree relative with bipolar disorder or a psychotic disorder
2. past history of behavioural activation or suicidal ideations on antidepressant medication
3. known hypersensitivity to Vortioxetine
4. concomitant use of other antidepressants
5. current participation in CBT for HD or OCD
6. concomitant use of a MAO inhibitor
7. known hepatic insufficiency
8. pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT04035850
Study Brief:
Protocol Section:
NCT04035850