REStoring mood after Early life Trauma – Glucocorticoid Receptor (GR) blockade as disease-modifying treatment for depression with childhood trauma

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 158

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 (MINI)
•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
•A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of
the following conditions applies:
o Is not a WOCBP
o Is a WOCBP and agrees to use an acceptable non-hormonal contraceptive method (e.g. condom, also if
hormonal contraceptive method is used) during the intervention period and up to 1 month after the
intervention. A WOCBP must have a negative highly sensitive pregnancy test before the first dose of the study
intervention.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 158
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential participant who meets any of the following criteria will be excluded from participation in this study:
•Primary diagnosis of post-traumatic stress disorder (PTSD) or Acute Stress disorder (ASD)
•Lifetime diagnosis of borderline personality disorder (BPD)
•Current alcohol/drug dependence or other severe psychiatric comorbidity (e.g. bipolar disorder, schizophrenia) that
requires clinical attention.
•Start of other forms of depression treatment in the week before or after the start of intervention.
•Female participant being a WOCBP who do not agree to use an acceptable non-hormonal contraceptive method
(e.g. condom, also if hormonal contraceptive method is used) during the intervention period and up to 1 month after
the intervention.
•Female participants that are pregnant or breastfeeding. Pregnancy is excluded using a negative highly sensitive
pregnancy test before the first dose of the study medication during the baseline visit.
•Female participants that have a history of unexplained vaginal bleeding or endometrial changes
•Chronic adrenal insufficiency
•Current use of:
o Medications containing CYP3A4-inhibitors, as an interaction of CYP3A4-inhibitors and mifepristone leads to higher
mifepristone plasma levels and increases the chance of having side effects. This also includes the consumption of
grapefruit juice during the intervention
o Medications containing CYP3A4-inductors, as an interaction of CYP3A4-inductors and mifepristone leads to lower
mifepristone plasma levels and decreases the chance of having a beneficial effect. This also includes the consumption
of St John’s worth /hypericum perforatum during the intervention.
o Glucocorticoid antagonists within 1 week before possible start of trial treatment.
o Systemic corticosteroids. Topical corticosteroid treatment are acceptable, with the exception of inhaled
corticosteroids (inhalators).

Before randomization, all currently used medications will be reviewed by a pharmacologist from the hospital pharmacy to prevent toxicity or interaction with mifepristone.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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