Study on MDMA-Assisted Therapy for Patients with Treatment-Resistant PTSD

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Posttraumatic Stress Disorder (PTSD), a mental health condition that can occur after experiencing or witnessing a traumatic event. The treatment being tested is called MDMA-assisted therapy, which involves the use of a medication known as 3,4-methylenedioxymethamphetamine hydrochloride (MDMA HCl). This medication is administered in capsule form and is taken orally. The purpose of the study is to evaluate how this therapy affects the symptoms of PTSD.

Participants in the study will receive MDMA-assisted therapy in a high-intensity inpatient setting. This means that the treatment will be provided in a controlled environment where participants stay for a period of time to receive therapy. The study is designed to observe changes in PTSD symptoms over a specific period. Participants will be monitored and assessed to understand how the therapy impacts their condition.

The study aims to provide insights into whether MDMA-assisted therapy can be an effective treatment for individuals with PTSD who have not responded to other treatments. By participating in this study, researchers hope to gather valuable information that could lead to new treatment options for those affected by PTSD. The study will follow a structured course, but specific technical details are not included in this description.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be at least 18 years old and have a diagnosis of posttraumatic stress disorder (PTSD) for at least 6 months. A score of 40 or greater on the PTSD Checklist for DSM-5 (PCL-5) is required, indicating moderate to severe PTSD. Participants must have previously undergone at least two trauma-focused psychotherapies.

2 baseline assessment

A baseline assessment is conducted to evaluate the severity of PTSD symptoms using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). This assessment helps establish a starting point for measuring changes in symptoms throughout the study.

3 treatment sessions

Participants receive MDMA-assisted therapy. The medication used is 3,4-methylenedioxymethamphetamine hydrochloride, administered orally in capsule form. The frequency and dosage are determined by the study protocol and are designed to assist in psychotherapy sessions.

4 follow-up assessments

Follow-up assessments occur at various intervals to monitor changes in PTSD symptoms and overall functioning. The primary measure is the change in CAPS-5 Total Severity Score from the baseline to 12 weeks post-baseline. Secondary measures include changes in the Sheehan Disability Scale (SDS) scores and tracking of screen failures and dropouts.

5 completion of study

The study is estimated to conclude by November 1, 2025. Participants’ progress and outcomes are evaluated to determine the effectiveness of MDMA-assisted therapy for treatment-refractory PTSD.

Who Can Join the Study?

Must be at least 18 years old at the time of signing the informed consent.
Must meet the DSM-5 criteria for current PTSD (posttraumatic stress disorder) with symptoms lasting at least 6 months.
Must have a PCL-5 score of 40 or greater, indicating moderate to severe PTSD. The PCL-5 is a questionnaire used to measure PTSD symptoms.
Must have treatment-refractory PTSD, meaning they have tried at least two different trauma-focused therapies, each consisting of at least 10 sessions, without success.

Who Cannot Join the Study?

Individuals who do not have posttraumatic stress disorder (PTSD) cannot participate. PTSD is a condition that can develop after experiencing or witnessing a traumatic event.
Participants must be within a specific age range, typically adults, to be eligible.
Both males and females are eligible, but certain gender-specific criteria may apply.
Individuals who are considered part of a vulnerable population, such as those unable to give informed consent, are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Avx Nibfevyl Pmhdyxfisdpf Cdjhak	Diemen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.04.2025

Trial locations

Investigated drugs:

Midomafetamine Hydrochloride

MDMA is a medication used in this study to assist psychotherapy for individuals with treatment-resistant Posttraumatic Stress Disorder (PTSD). It is known for its potential to enhance emotional openness and reduce fear, which may help patients process traumatic memories more effectively during therapy sessions.

Investigated diseases:

Post-traumatic stress disorder

Posttraumatic Stress Disorder – This 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, avoidance of reminders of the trauma, and heightened reactions to stimuli. The disorder can develop shortly after the traumatic event or may appear years later. Symptoms can vary in intensity over time and may be exacerbated by stress or reminders of the trauma. The progression of PTSD can significantly impact daily functioning and relationships.

Trial ID:

2023-508229-28-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on MDMA-Assisted Therapy for Patients with Treatment-Resistant PTSD

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