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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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.

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
randomization.
• 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 to
prevent toxicity or interaction with mifepristone.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Improvement in depressive symptom severity (IDS-SR score), 6 weeks after the<br /><br>start of the intervention. </p><br>

Secondary Outcome Measures

Name	Time	Method

Related Trials