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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT03972033
Eligibility Criteria:
Inclusion Criteria:
1. a diagnosis of Major Depressive Disorder, single episode or recurrent, according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
2. a score of at least 20 on Beck's Depression Inventory-II (BDI-II);
3. having received ADM treatment with a stable dose for at least six weeks and maintained stable during treatment;
4. legal capacity to consent to the treatment.
Exclusion Criteria:
1. diagnosis of current PTSD (assessed with MINI-Plus and the International Trauma Questionnaire - ITQ, Cloitre et al., 2018);
2. diagnosis of complex PTSD (assessed with the ITQ);
3. history of psychotic symptoms or schizophrenia;
4. bipolar disorder or dementia;
5. cluster A and B severe personality disorders;
6. dissociative symptoms (DES-B score \>2);
7. any substance-related abuse or dependence disorder (except those involving nicotine) in the 6 months prior to the study;
8. a serious, unstable medical condition;
9. a severely unstable social and economic condition (e.g. no fixed abode; job loss without any other source of income);
10. being pregnant;
11. acute suicidality that needs hospitalization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03972033
Study Brief:
Protocol Section:
NCT03972033