Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2020-003385-40-NL
EUCTR2020-003385-40-NLActive, not recruitingPhase 1

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

Amsterdam UMC, location VUmc0 sites158 target enrollmentStarted: February 24, 2021Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
158
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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.

Investigators

Sponsor
Amsterdam UMC, location VUmc

Similar Trials

Recruiting
Phase 2
REStoring mood after Early life Trauma - Glucocorticoid Receptor (GR) blockade as disease-modifying treatment for depression with childhood traumaChildhood trauma related depression10027946
NL-OMON52484Vrije Universiteit Medisch Centrum158
Recruiting
Not Applicable
REStoring mood after Early life Trauma - the effectiveness of trauma-focused therapy in patients with depression and childhood trauma10027946Childhood TraumaDepressionMajor Depressive Disorder
NL-OMON54461Vrije Universiteit Medisch Centrum158
Active, not recruiting
Not Applicable
a reviviscence dans l'état de stress post-traumatique : une pathologie du rappel émotionnel ? Application thérapeutique - VIVITRAa reviviscence dans l'Etat de Stress Post-TraumatiqueMedDRA version: 8.1Level: PTClassification code 10036316
EUCTR2006-006386-16-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Completed
Not Applicable
Extinction of Fear Memories With Glucocorticoids in Veterans With PTSDPosttraumatic Stress Disorder
NCT01090180VA Office of Research and Development129
Completed
Not Applicable
Rehabilitation of attention following traumatic brain injury: A model for methylphenidateTraumatic brain injuryPhysical Medicine / Rehabilitation - Other physical medicine / rehabilitation
ACTRN12607000503426Ms. Catherine Willmott40