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Taking peoplePhase 4

Cortisol in personalized treatment for posttraumatic stress disorder (PTSD)

Key facts

Who runs it
Stichting Radboud universitair medisch centrum
Where
Netherlands3 sites in 1 countryChoose a country to see its sites
Status
Recruiting
Phase
Phase 4
People taking part
190 people, planned
Started
28 Oct 2024
Planned end
1 Jul 2026
Type of study
Interventional
Record updated
5 November 2026

Who can take part

Age
18 years to 64 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • Patient group: Participants with PTSD (n = 160) will be recruited (1) at collaborating treatment centres, before the start of their trauma-focused therapy treatment, when they have at least a suspected PTSD diagnosis with an indication for trauma-focused therapy, or (2) independently from treatment centres, when they declare to have received a PTSD diagnosis by a doctor or specialist and currently experience considerable PTSD symptoms; these participants will be screened with a PTSD diagnostic interview (CAPS-5) to confirm current PTSD diagnosis (otherwise exclusion).Patients must be aged 18-64. If applicable, the expected waiting time until treatment is sufficient for participation, at least for part A of the study, with minimal overlap with treatment beng allowed (as specified in research protocol). Progression of patients into substudy B follows based on additional screening criteria, interest and feasibility. Control group: Healthy, non-trauma exposed control participants (n = 30) will be recruited from the general population in and around Nijmegen. Control participants only complete assessments from substudy A. Control participants must be aged 18-64 years. Inclusion criteria are no history of psychiatric disorders, and no history of childhood maltreatment. Hence, this group will reflect a healthy, non-trauma exposed control group, Control participants will be selected based on age, gender and education, with the aim to match the distributions of these relevant basic demographic variables to the (expected) distributions of the included patient group

Who cannot take part

  • Patient group: • Current episode of psychotic or manic symptoms. • Daily intake of benzodiazepines, or otherwise irregular intake of benzodiazepines ("when needed") but unable to withhold intake from the day prior to each test session until the end of the each test session. An exception is made for low doses of short-acting benzodiazepines that are prescribed for insomnia (i.e. as sleep medication). • A relevant neurological disorder (e.g., stroke, epilepsy, Multiple Sclerosis) or severe physical disorder which is likely to impact assessment procedures or results. • Reports to be unable or unwilling to withhold recreational drug use and limit alcohol use from the day prior to each test session until the end of the each test session. • General learning disability, or known to have intelligence Quotient (IQ) < 80 • Body Mass Index (BMI) of >35. • If relevant, endocrine disorder and/or current or recent endocrine treatment (<1 month ago; for e.g., phechromocytoma, hyperthyroidism, Cushing's syndrome). • Current or recent regular use of corticosteroids (<1 month ago). • For women: Pregnancy. • Reports hypersensitivity to hydrocortisone or any of the tablet's auxiliary agents. • (Only for part B) Contraindications for MRI scanning (e.g., pacemaker, implanted metal parts, metal in or around the body, deep brain stimulation, severe claustrophobia). Note: based on the exclusion criteria above, it may be decided by the research team that a participant should onlyparticipate in part A of the study, but will be excluded from part B of the study Control group: • History of childhood maltreatment • Current or past psychiatric disorder • Use of psychotropic medication • Relevant neurological disorder (e.g., stroke, epilepsy, Multiple Sclerosis) or severe physical disorder which is likely to impact assessment procedures or results. • Reports to be unable or unwilling to withhold recreational drug use and limit alcohol use from the day prior to each test session until the end of the each test session. • General learning disability, or known to have intelligence Quotient (IQ) < 80 • Body Mass Index (BMI) of >35. • If relevant, endocrine disorder and/or current or recent endocrine treatment (<1 month ago; for e.g., phechromocytoma, hyperthyroidism, Cushing's syndrome). • Current or recent regular use of corticosteroids (<1 month ago). • For women: Pregnancy

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 64 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Substudy A: To investigate, within a sample of PTSD patients, the associations between history of early life adversity (ELA), epigenetic mechanisms, and HPA axis dysregulation. Substudy B: To investigate whether the subgroup of PTSD patients with HPA axis dysregulation particularly benefits from glucocorticoid augmentation (hydrocortisone administration) of safety learning, as indicated by greater reductions in the physiological fear response to a conditioned stimulus after extinction.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Targeted glucocorticoid administration to improve safety learning in posttraumatic stress disorder patients with HPA axis dysregulation
Fit questions
Built from 2024-516427-13-00, who can take part
Record updated
5 November 2026