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Title: Study of Hydrocortisone Treatment to Improve Fear Response in Adults with Post-Traumatic Stress Disorder (PTSD) and Hormonal System Changes

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What is this study about?

This clinical trial focuses on patients with Posttraumatic Stress Disorder (PTSD), a condition that can develop after experiencing traumatic events. The study aims to understand how early life stress affects the body’s stress response system and to test whether treatment with hydrocortisone (a stress hormone medication) can help improve therapy outcomes in certain PTSD patients.

The study consists of two parts. In the first part, researchers will examine how childhood difficulties affect the body’s stress system in people with PTSD. In the second part, some participants will receive either hydrocortisone tablets (20 mg) or a placebo to see if the medication can help them learn to feel safe in situations that previously caused fear responses.

During the study, participants will provide saliva samples to measure stress hormones and undergo various assessments in a safe environment using virtual reality technology. Some participants will also have brain scans to help researchers understand how the treatment affects brain activity. The medication is taken by mouth in the form of tablets, and the study includes regular check-ups to monitor participants’ well-being.

1 Initial evaluation

Your participation begins with confirming your PTSD diagnosis through a specialized interview called CAPS-5 if you were not referred by a treatment center.

The study is designed for individuals aged 18-64 who have post-traumatic stress disorder.

2 Substudy A participation

You will provide saliva samples to measure your body’s stress hormone (cortisol) response during a standardized stress test.

The study will examine the relationship between your early life experiences and your body’s stress response system.

Your participation in this phase may continue while you are waiting to begin trauma-focused therapy.

3 Substudy B participation

If you qualify for this phase, you will participate in a safety learning exercise using virtual reality.

You will receive either hydrocortisone tablets (20 mg) or a placebo capsule taken by mouth.

Brain imaging (MRI scans) will be performed to observe your brain’s response during emotional tasks and while viewing different facial expressions.

The scanning will also examine the connection between different areas of your brain and collect detailed images of your brain structure.

4 Study duration

The study continues until July 2026.

Your individual participation timeline will be determined based on your specific study involvement.

Who Can Join the Study?

  • Age between 18 and 64 years old
  • Must have received a PTSD diagnosis from a doctor or specialist
  • Must be currently experiencing significant PTSD symptoms
  • Must be either:
    • Starting trauma-focused therapy with at least a suspected PTSD diagnosis, or
    • Independent from treatment centers but willing to complete a diagnostic interview to confirm PTSD diagnosis
  • If currently in treatment, the waiting time until treatment should be sufficient to participate in part A of the study
  • Both men and women can participate
  • For healthy control group participants only:
    • No history of psychiatric disorders
    • No history of childhood maltreatment
    • Must match patient group in terms of age, gender, and education level

Who Cannot Join the Study?

  • Current or history of psychotic disorders (conditions that cause loss of contact with reality)
  • Current bipolar disorder (a mental health condition causing extreme mood swings)
  • Current substance use disorder (except nicotine and caffeine)
  • Serious or unstable medical conditions that could interfere with participation
  • Current pregnancy or breastfeeding
  • Use of systemic corticosteroids (medications like prednisone) in the past 3 months
  • Current use of medications that could interfere with the study procedures
  • History of severe allergic reactions to medications
  • Inability to provide informed consent
  • Participation in another clinical trial within the past 30 days
  • Presence of any condition that could make participation unsafe
  • History of traumatic brain injury with loss of consciousness lasting more than 30 minutes
  • Active thoughts of self-harm or suicide
  • Unable to communicate effectively in the study language

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Radboudumc Nijmegen The Netherlands

Other Sites

Site Name City Country Status
Ptgrkevahqpopv vcvr Fwlzapowxjv Pqlciygwatsx Kabvvt Nijmegen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
18.01.2021

Trial locations

Investigated drugs:

Hydrocortisone is a medication that belongs to a group of drugs called glucocorticoids, which are similar to the natural stress hormone cortisol produced by the body. In this trial, it is being studied to help patients with Post-Traumatic Stress Disorder (PTSD) who have difficulties with their body’s stress response system. The medication may help improve the way these patients learn to feel safe in situations that previously triggered fear responses. Hydrocortisone is thought to work by regulating the body’s stress response system and potentially enhancing the brain’s ability to learn new, safer associations.

Investigated diseases:

Post-traumatic Stress Disorder (PTSD) – A mental health condition that develops in some people after experiencing or witnessing a traumatic event. The condition involves persistent intrusive memories, flashbacks, and nightmares related to the traumatic experience. People with PTSD often experience heightened anxiety, emotional numbness, and strong reactions to reminders of the trauma. The condition affects daily functioning and can cause sleep problems, difficulty concentrating, and changes in emotional responses. PTSD can develop immediately after trauma or may emerge months or years later.

Trial ID:
2024-516427-13-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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