NCT05217758CompletedPhase 2
RESET-medication Glucocorticoid Receptor (GR) Blockade As Disease Modifying Treatment for Depression with Childhood Trauma
RESET-medication: Glucocorticoid Receptor (GR) Blockade As Diseasemodifying Treatment for Depression with Childhood Trauma
Source: ClinicalTrials.gov · Last updated 6 Dec 2024
Brief summary (registry, in English)
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 does not respond to currently used evidence-based treatments. The heterogeneous nature of depressive symptoms is a major obstacle for the development of novel effective treatments, and targeted treatments for depression are currently lacking. The investigators propose a targeted disease-modifying treatment for the clinically distinct form of depression related to childhood trauma (CT, emotional/ physical/sexual abuse or neglect before the age of18). CT-related depression is critically different from non-CT depression: it emerges earlier in life with more severe and recurrent symptoms and less favorable responses to treatment. With an average 25% prevalence in depression, there is a large and unmet need for therapeutic strategies to treat depression in individuals with substantial CT. The GR is the major cortisol receptor in the brain and rodent studies have shown that GR blockade at adult age can reverse the effects of early-life adversity. Therefore, GR blockade is a potential novel treatment for CT-related depression but this has never been investigated. Based on the underlying stress neurobiology, the aim is to investigate whether the biological sequelae of excessive stress due to CT can be targeted by blocking the glucocorticoid receptor (GR) using the generic drug mifepristone.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 158 (actual)
- First submitted
- 20 Dec 2021
- Start date
- 9 Dec 2021
- Primary completion date
- 9 Aug 2024
- Lead sponsor
- Amsterdam UMC, location VUmc
- Diseases
- Depression
- NCT number
- NCT05217758
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 158
- From 9 Dec 2021 to the primary completion date, 9 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Start of other forms of depression treatment in the week before or after the start of the intervention.
- 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).
Other illness
- 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.
- Female participants that have a history of unexplained vaginal bleeding or endometrial changes.
- Chronic adrenal insufficiency (contraindication for mifepristone).
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC location VUmc Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.