Phase 2 PTSD Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who speak and understand Dutch fluently
• People who are 18 years of age or older and are able to provide written consent to participate
• People who agree to be randomly assigned to a treatment group
• People who have been diagnosed with PTSD (Post-Traumatic Stress Disorder) according to recognised diagnostic standards, confirmed through a structured clinical interview
• People whose PTSD is considered treatment-resistant, meaning their symptoms remain severe (a score of 30 or higher on a standard PTSD assessment scale) and they have not responded to at least two recommended, properly delivered treatments for PTSD — including at least one full course of trauma-focused therapy

Who may not be able to join:

• People who have bipolar disorder, a psychotic disorder, or a current serious problem with alcohol or drug dependence that needs clinical treatment
• Women who are capable of becoming pregnant and are not willing to use a non-hormonal contraceptive method (such as a condom) during the treatment period and for one month after it ends
• Women who are currently pregnant or breastfeeding (a pregnancy test will be carried out before the first dose of the study medication)
• Women who have a history of unexplained vaginal bleeding or changes to the lining of the uterus
• People who have a long-term condition where the adrenal glands do not produce enough hormones (chronic adrenal insufficiency)
• People who are currently taking certain medications that interact with the study drug, including those that affect how the body processes it (known as CYP3A4-inhibitors or CYP3A4-inductors) — this also includes drinking grapefruit juice or taking St John's Wort during the treatment period (confirm with trial site)
• People currently taking other specific categories of medications that may interact with the study drug, including CYP3A4 substrates, CYP2C8/9 substrates, or certain drugs transported by specific proteins in the body (P-gp and BCRP) (confirm with trial site)
• People who have taken glucocorticoid-blocking medications within one week before the possible start of the trial
• People who are currently taking corticosteroid medications taken throughout the body (systemic), or inhaled corticosteroids — note that creams or ointments applied to the skin are generally acceptable
• People whose current medication doses are not yet stable (for example, those who are in the process of reducing their antidepressant dose)

Important: Always verify eligibility with the trial site directly before applying.