Study on Mifepristone for Patients with Treatment-Resistant Post-Traumatic Stress Disorder (PTSD)

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What is this study about?

This clinical trial is focused on studying a condition known as Post-Traumatic Stress Disorder (PTSD), which is a mental health condition triggered by experiencing or witnessing a traumatic event. The study aims to explore the effectiveness of a medication called mifepristone, which is a glucocorticoid receptor antagonist. This means it works by blocking certain receptors in the body that are involved in the stress response. The trial will compare the effects of mifepristone to a placebo, which is a tablet that looks like the medication but does not contain any active ingredients.

The purpose of the study is to determine if mifepristone can help reduce the severity of PTSD symptoms in individuals who have not responded to other treatments. Participants in the study will take mifepristone for a period of seven days, with a daily dose of 1200 milligrams. The study will monitor changes in PTSD symptoms over several weeks to assess the medication’s effectiveness. The trial will involve regular assessments to track the progress of symptoms and any changes in the participants’ condition.

Throughout the study, participants will be evaluated using various tools to measure PTSD symptoms and other related factors such as sleep quality, stress levels, anxiety, and depression. The study will last for several months, with follow-up assessments to understand the long-term effects of the treatment. This research aims to provide new insights into managing treatment-resistant PTSD and improving the quality of life for those affected by this challenging condition.

1 randomization

Upon joining the study, the participant is randomly assigned to one of two groups. One group receives mifepristone, and the other receives a placebo. This process ensures that the study results are unbiased.

2 medication administration

Participants in the mifepristone group take the medication orally at a dose of 1200 mg per day for 7 days. Participants in the placebo group take a similar-looking pill with no active ingredients for the same duration.

3 initial assessment

Four weeks after starting the medication, an assessment is conducted to measure the severity of PTSD symptoms using the Clinician Administered PTSD Scale (CAPS-5). This helps determine the initial effectiveness of the treatment.

4 ongoing assessments

Weekly assessments are conducted using the PTSD Checklist for DSM-5 (PCL-5) to monitor symptom changes from the start of the intervention until 12 weeks later. These assessments help track progress over time.

5 long-term assessment

At 12 weeks after starting the intervention, a long-term assessment is conducted using the CAPS-5 to evaluate the sustained impact of the treatment on PTSD symptoms.

6 additional evaluations

Additional evaluations are performed at 1, 4, and 12 weeks after starting the intervention. These include assessments of disability, sleep quality, stress levels, anxiety symptoms, depressive symptoms, and suicidal thoughts or behaviors.

Who Can Join the Study?

Must speak and understand Dutch.
Must be 18 years or older and able to provide written consent.
Must agree to be randomly assigned to different treatment groups.
Must have a diagnosis of Post-traumatic stress disorder (PTSD), confirmed through a clinical interview using a specific scale called CAPS-5.
Must have treatment-resistant PTSD, which means having a CAPS-5 score of 30 or higher and not responding to two recommended treatments for PTSD, including at least one full course of therapy focused on trauma.

Who Cannot Join the Study?

Individuals who are not diagnosed with Post-traumatic stress disorder (PTSD) cannot participate.
Participants must be adults, as the study is not open to children or teenagers.
Both men and women can participate, so gender is not a reason for exclusion.
People who are part of a vulnerable population, such as those unable to give consent, are not included in this study.
Participants must have treatment-resistant PTSD, meaning their PTSD symptoms have not improved with previous treatments.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ayymteocc Ujf	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	03.06.2024

Trial locations

Investigated drugs:

Mifepristone: This medication is being studied to see if it can help reduce the severity of symptoms in people with treatment-resistant Post Traumatic Stress Disorder (PTSD). It works by blocking certain receptors in the body, which may help in managing PTSD symptoms. The trial is testing whether this medication is more effective than not taking any active medication.

Investigated diseases:

Post-traumatic stress disorder

Post-traumatic stress disorder (PTSD) – PTSD is a mental health condition triggered by experiencing or witnessing a traumatic event. It is characterized by symptoms such as flashbacks, nightmares, severe anxiety, and uncontrollable thoughts about the event. Individuals with PTSD may also experience emotional numbness, irritability, and difficulty sleeping. The symptoms can vary in intensity and may become more severe when the person is stressed or reminded of the trauma. Over time, these symptoms can interfere with daily functioning and relationships. The progression of PTSD can be chronic, with symptoms lasting for months or even years if not addressed.

Trial ID:

2024-511042-39-00

Protocol code:

REVERSE

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Mifepristone for Patients with Treatment-Resistant Post-Traumatic Stress Disorder (PTSD)

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