Status:
COMPLETED
RESET-medication Glucocorticoid Receptor (GR) Blockade As Disease Modifying Treatment for Depression with Childhood Trauma
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Netherlands Brain Foundation
Corcept Therapeutics
Conditions:
Major Depressive Disorder
Childhood Trauma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Depression is a recurrent debilitating psychiatric disorder with a lifetime prevalence of 20%. Even though antidepressants and psychotherapy are often effective, a substantial proportion of patients d...
Detailed Description
Rationale: Depression is a recurrent debilitating psychiatric disorder with a lifetime prevalence of 20%. Even though antidepressants and psychotherapy are often effective, a substantial proportion of...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2024
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT05217758
Start Date
December 9 2021
End Date
November 12 2024
Last Update
December 6 2024
Active Locations (1)
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1
Amsterdam UMC, location VUmc
Amsterdam, North Holland, Netherlands, 1081HV