MIFEPRISTONE for Post-traumatic stress disorder | Treatment-resistant post-traumatic stress disorder

Inclusion criteria

• {"criterion_text":"- Mastery of Dutch language"}
• {"criterion_text":"- Age of ≥ 18 years of age and able to give written consent"}
• {"criterion_text":"- Participant agrees to be randomized"}
• {"criterion_text":"- DSM-5 diagnosis of PTSD, confirmed with clinical interview (CAPS-5)"}
• {"criterion_text":"- Treatment-resistant PTSD: CAPS-5 score ≥ 30 and nonresponse to two evidence-based treatments for PTSD recommended by a recent clinical practice guidelines delivered with fidelity and at an effective dose, at least one of which is a full course of trauma-focused psychotherapy."}

Exclusion criteria

• {"criterion_text":"- Bipolar disorder, psychotic disorder, or current alcohol/drug dependence that requires clinical attention."}
• {"criterion_text":"- Female participant being a WOCBP and who does not want to use a non-hormonal contraceptive method (condom) during the intervention period and up to 1 month after the intervention."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Female participants that have a history of unexplained vaginal bleeding or endometrial changes."}
• {"criterion_text":"- Chronic adrenal insufficiency."}
• {"criterion_text":"- Current use of medications containing: CYP3A4-inhibitors/inductors/substrates, CYP2C8/9 substrates, P-gp and BCRP transported drugs, glucocorticoid antagonists, systemic corticosteroids or unstable drug dosages (tapering/titrating antidepressants)."}

Primary endpoints

• {"endpoint_text":"- To investigate whether mifepristone (7-day, 1200 mg/day) is more efficacious than placebo in reducing PTSD symptom severity 4 weeks after the start of the intervention, as measured with the monthly version of the CAPS-5 (Clinician Administered PTSD scale) in patients with treatment-resistant PTSD.","definition_or_measurement_approach":"Measured with the monthly version of the CAPS-5 (Clinician Administered PTSD scale) at 4 weeks after the start of the intervention."}

Secondary endpoints

• {"endpoint_text":"- PTSD symptom severity as measured with the weekly version of the PCL-5, from baseline till 12 weeks after the start of the intervention (T3).","definition_or_measurement_approach":"Measured with the weekly version of the PCL-5 from baseline until 12 weeks after the start of the intervention."}
• {"endpoint_text":"- Long-term PTSD symptom severity as measured with the CAPS-5, at 12 weeks after the start of the intervention (T3).","definition_or_measurement_approach":"Measured with the CAPS-5 at 12 weeks after the start of the intervention."}
• {"endpoint_text":"- Loss of diagnosis (score of <26 and absence of PTSD criteria with CAPS-5), 4 weeks after the start of the intervention.","definition_or_measurement_approach":"Defined as CAPS-5 score <26 and absence of PTSD criteria on CAPS-5 assessed 4 weeks after start of intervention."}
• {"endpoint_text":"- Treatment response (minimum decrease of 10 point on the PCL-5 and CAPS-5 scores) at 1, 4 and 12 weeks after the start of the intervention.","definition_or_measurement_approach":"Treatment response defined as minimum decrease of 10 points on PCL-5 and CAPS-5, assessed at 1, 4 and 12 weeks after intervention start."}
• {"endpoint_text":"- Other clinical outcomes 1, 4, and 12 weeks after the start the intervention: o disability (WHO Disability Schedule 2.0; WHO-DAS II), o sleep (Insomnia Severity Index; ISI), o subjective stress (Perceived Stress Scale; PSS), o anxiety symptoms (Beck Anxiety Inventory; BAI), o depressive symptoms (IDS-SR), o suicidal ideation and behaviour (Columbia-Suicide Severity Rating Scale).","definition_or_measurement_approach":"Multiple instruments: WHO-DAS II for disability; ISI for sleep; PSS for subjective stress; BAI for anxiety; IDS-SR for depressive symptoms; C-SSRS for suicidal ideation and behaviour, assessed at 1, 4 and 12 weeks after intervention start."}

Netherlands

Latest Decision Or Authorization Date

24-02-2026

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands