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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT02883660
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years or older
2. Able to give informed consent prior to the initiation of any protocol required procedures.
3. Subject must be able to understand the nature of the study, agree to comply with the study procedures, and communicate about medical history to the study personnel.
4. Subject was treated with one of the following "target antidepressants:" Escitalopram, citalopram, paroxetine, fluvoxamine, venlafaxine, duloxetine, bupropion, vortioxetine, vilazodone, and levomilnacipran. Rationale: These antidepressants are primarily metabolized by CYP isoenzymes that will be assessed. Antidepressants like sertraline, fluoxetine, and mirtazapine are metabolized by multiple CYP isoenzymes and therefore are less likely to be significantly affected by metabolizer status on a particular CYP isoenzyme. For patients who have been treated with multiple antidepressants, the antidepressant that was associated with the greatest overall burden of AEs will be selected as the target antidepressant.
5a. Study group: "Increased AEs" currently or in the past on one of the target antidepressants as operationally defined as either A or B: A) One or more AEs that were moderate/severe OR three or more AEs that were mild occurring on less than the usual minimum recommended dose of the antidepressant, or B) Three or more AEs that were moderate/severe OR five or more AEs that were mild on a dose of the antidepressant within the usual recommended dose 5b. Control group: Both A and B A. Less than 30% reduction in the severity of depression after treatment for at least 6 weeks B. Minimal or no AEs on that antidepressant
Exclusion Criteria:
1. Subjects on antidepressants other than those specified in the inclusion criteria.
2. Subjects for whom it is unclear which medication caused the adverse events
3. Subjects for whom participation in the study would be detrimental to their mental of physical health based on investigator's opinion
4. Subjects who have had a medical condition that, in the investigator's judgment, may be causing the reported adverse events
5. Prisoners or patients who are involuntarily incarcerated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02883660
Study Brief:
Protocol Section:
NCT02883660