Improving treatment-resistant PTSD with a glucocorticoid receptor blocker

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of mifepristone, a glucocorticoid receptor antagonist, to treat individuals with treatment-resistant post-traumatic stress disorder (PTSD). The study aims to determine if blocking cortisol's effects can alleviate PTSD symptoms in patients who have not responded to standard treatments. Participants will be randomly assigned to receive either mifepristone or a placebo, and their PTSD symptoms will be assessed using the CAPS-5 scale. The trial focuses on adults who have experienced significant trauma and have not benefited from previous evidence-based therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Mastery of Dutch language
* Age of ≥ 18 years of age and able to give written IC
* Participant agrees to be randomized
* DSM-5 diagnosis of PTSD, confirmed with clinical interview (CAPS-5)
* Treatment-resistant PTSD

  * CAPS-5 score ≥ 30
  * 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:

* 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, 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
  * Medications containing CYP3A4-inductors, as an interaction of CYP3A4-inductors and mifepristone leads to lower mifepristone plasma levels and decreases the chance of having a beneficial effect. This also includes the consumption of St John's worth/hypericum perforatum during the intervention.
  * Medications containing CYP3A4 substrates.
  * Medications containing CYP2C8/9 substrates.
  * Medications containing P-gp and BCRP transported drugs
  * 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).
  * Unstable drug dosages (e.g. tapering of antidepressants).

Where it's running

• Amsterdam UMC, location VUmc
  Amsterdam, North Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Christiaan Vinkers, Prof.
• Email: c.vinkers@amsterdamumc.nl

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.