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REVERSE: a randomized controlled trial (RCT) to ameliorate treatment-resistant Post Traumatic Stress Disorder (PTSD) with Glucocorticoid Receptor (GR) antagonism
EU CTIS ID: 2024-511042-39-00
What this study is testing
To investigate whether mifepristone (7-day, 1200 mg/day) is more efficacious than placebo in reducing PTSD symptom severity (Clinician Administered PTSD scale, CAPS-5) in patients with treatment-resistant PTSD in a randomized controlled trial.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Mastery of Dutch language
- Age of ≥ 18 years of age and able to give written consent
- Participant agrees to be randomized
- DSM-5 diagnosis of PTSD, confirmed with clinical interview (CAPS-5)
- 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.
You likely can't join if
- Bipolar disorder, psychotic disorder, or current alcohol/drug dependence that requires clinical attention.
- 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.
- 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 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.