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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT03187093
Eligibility Criteria:
Inclusion Criteria:
* Outpatient 18 to 65 years of age
* Meets DSM-5 criteria for MDD
* Depressive episode duration ≥ 2 months
* The participant has MARDS total score ≥ 7
* Free of psychotropic medications for at least 5 half-lives before baseline
* Fluent in Russian/Ukrainian
Exclusion Criteria:
* Current diagnosis or history of manic/hypomanic episode
* Any other psychiatric diagnosis that is considered the primary diagnosis
* Any significant personality disorder diagnosis
* High suicidal risk, defined by clinician judgment
* Substance dependence/abuse in the past year
* Significant neurological disorders, head trauma, or other unstable medical conditions
* History of endocrinological diseases
* Pregnant or breastfeeding
* Psychosis in the current episode
* High risk for hypomanic switch
* Cognitive or language impairment of such severity as to adversely affect the performance of tests
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03187093
Study Brief:
Protocol Section:
NCT03187093