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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT03628027
Eligibility Criteria:
Inclusion Criteria:
* age 18 years +
* at least moderately severe major depressive syndrome on PHQ-9 (score 15 +)
* no plans to change GP practice
* able to complete self-report scales orally or in writing
* no previous prescription of mirtazapine or vortioxetine
* early treatment resistance as defined by 1) current or recent prescription (in the last 2 months) of any of the following antidepressants: citalopram, fluoxetine, sertraline, escitalopram, paroxetine, venlafaxine, or duloxetine AND 2) previous prescription of at least one other antidepressant out of the same list.
Exclusion Criteria:
* inability to consent to study
* unstable medical condition
* currently receiving specialist psychiatric treatment
* high suicide risk (MINI suicidality screen)
* past diagnosis of schizophrenia or schizo-affective disorder
* current psychotic symptoms (3 clinical screening questions)
* bipolar disorder
* currently at risk of being violent
* drug (modified PHQ) or alcohol abuse (PHQ) over last 6 months
* suspected central neurological condition
* pregnancy or insufficient contraception in women of childbearing age
* breastfeeding or within 6 months of giving birth in women of childbearing age
* both escitalopram and sertraline have already been prescribed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03628027
Study Brief:
Protocol Section:
NCT03628027