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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT05217758
Eligibility Criteria:
Inclusion Criteria:
* Mastery of Dutch language
* Age of ≥ 18 years of age and able to give written IC
* Participant agrees to be randomized
* Moderate to severe depression; score ≥ 26 on the Inventory of Depressive Symptoms-Self Report (IDS-SR)
* DSM-5 diagnosis of major depression disorder (MDD), confirmed with clinical interview (M.I.N.I.-S)
* Moderate to severe childhood trauma (CT) before the age of 18; Score above validated cut-off for moderate to severe CT on one or more of the following domains using the Childhood Trauma Questionnaire (CTQ):
* physical neglect: score ≥ 10
* emotional neglect: score ≥ 15
* sexual abuse: score ≥ 8
* physical abuse: score ≥ 10
* emotional abuse: score ≥ 13
Exclusion Criteria:
* Primary diagnosis of post-traumatic stress disorder (PTSD) or Acute Stress Disorder (ASD)
* Lifetime diagnosis of borderline personality disorder (BPD)
* Other lifetime severe psychiatric comorbidity (e.g. bipolar disorder, schizophrenia) or current alcohol/drug dependence that requires clinical attention.
* Start of other forms of depression treatment in the week before or after the start of the intervention.
* Female participant being a WOCBP and who does not want to use a non-hormonal contraceptive method (e.g. condom) during the intervention period and up to 1 month after the intervention.
* Female participants that are pregnant or breastfeeding.
* Female participants that have a history of unexplained vaginal bleeding or endometrial changes.
* Chronic adrenal insufficiency (contraindication for mifepristone).
* Current use of:
* Medications containing CYP3A4-inhibitors
* Medications containing CYP3A4-inductors
* Glucocorticoid antagonists within 1 week before possible start of trial treatment.
* Systemic corticosteroids. Topical corticosteroid treatment are acceptable, with the exception of inhaled corticosteroids (inhalators).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05217758
Study Brief:
Protocol Section:
NCT05217758