Depression and post-traumatic stress disorder stress-related disorders Depression and post-traumatic stress disorder stress-related disorders
Conditions
Interventions
Participants will administer a single low dose of dexamethasone (0.25 mg) and a 
single dose of mifepristone (600 mg).
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: General inclusion criteria • Age between 18 and 65 years • Male • Mastery of Dutch language • Willingness and ability to give written informed consent Additional inclusion criteria MDD group • Moderate to severe depression, measured by a score of >= 26 on the Inventory of Depressive Symptoms-Self Report (IDS-SR). • DSM-5 diagnosis of MDD, confirmed with Mini International Neuropsychiatric Interview (MINI). Additional inclusion criteria PTSD group • Moderate to severe PTSD, measured by a score of >= 38 on the PTSD checklist for DSM-5 (PCL-5). • DSM-5 diagnosis of PTSD, confirmed with Mini International Neuropsychiatric Interview (MINI).
Exclusion criteria
Exclusion criteria: General exclusion criteria • Body mass index (BMI) <16 or >=30 • Current alcohol/drug dependence • Primary diagnosis of Acute Stress Disorder (ASD) • Lifetime diagnosis of borderline personality disorder (BPD) • Other lifetime severe psychiatric comorbidity (bipolar disorder, psychotic disorder) • Any acute somatic or acute endocrine disease (e.g., acute asthma) • Taking any medication known to influence endocrine systems • Any neurological disorder • Shift in sleep-wake rhythm, e.g. by working night shifts or having travelled across more than two timezones in the past two weeks. • Abdominal skin not accessible, e.g. by significant scarring. • Chronic adrenal insufficiency (contraindication for mifepristone). • 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, which might influence our findings. This also includes the consumption of St John*s worth /hypericum perforatum during the study. o Systemic corticosteroids. This includes topical corticosteroid treatments, as such treatments can affect HPA-axis functionality45. Before inclusion, all currently used medications will be reviewed by a pharmacologist from the hospital pharmacy to prevent toxicity or interaction with mifepristone. For dexamethasone, no specific contraindications apply. Additional exclusion criteria for healthy controls • Past or present psychiatric or neurological condition Additional inclusion criteria MDD group • Moderate to severe PTSD, measured by a score of >= 38 on the PTSD checklist for DSM-5 (PCL-5)44. • DSM-5 diagnosis of PTSD, confirmed with Mini International Neuropsychiatric Interview (MINI)1. Additional inclusion criteria PTSD group • Moderate to severe depression, measured by a score of >= 26 on the Inventory of Depressive Symptoms-Self Report (IDS-SR)43. • DSM-5 diagnosis of MDD, confirmed with Mini International Neuropsychiatric Interview (MINI)1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures are mean peak and trough values, the average difference between peaks and troughs and reactivity to single-dose GR agonism (dexamethasone) and antagonism (mifepristone). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures are stress in daily life (measured with the experience sampling method and wristbands to measure heart rate, skin conductance/temperature and movement), psychiatric symptoms and sleep duration and quality. | — |
Countries
Netherlands
Contacts
Public ContactP.T. Gajadien
Amsterdam UMC
Outcome results
None listed