Study on the Long-term Effects of Methylone for Treating PTSD in Patients

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What is this study about?

This clinical trial is focused on studying Post-Traumatic Stress Disorder (PTSD), a mental health condition that can occur after experiencing or witnessing a traumatic event. The study will evaluate the long-term effects of a treatment called Methylone, which is being tested in capsule form. Methylone is a chemical substance that is being investigated for its potential to help people with PTSD.

The purpose of the study is to assess how effective and safe Methylone is when used over a long period. Participants will receive either a single or repeated doses of Methylone over the course of the study. The study will last for 52 weeks, during which participants will be monitored to see how their symptoms change and to ensure their safety while taking the medication.

Throughout the study, various assessments will be conducted to measure the impact of Methylone on PTSD symptoms. These assessments will include evaluations of mental health, mood, and overall well-being. The study aims to provide valuable information on whether Methylone can be a beneficial treatment option for individuals living with PTSD.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing prior participation in trial number TT-TSND-201 (IMPACT-1).

2 treatment phase

The treatment involves taking a methylone capsule orally. The dosage is 50 mg per capsule.

The treatment is administered over a period of 52 weeks, with both single and repeated treatments evaluated for their long-term effects.

3 monitoring and evaluation

Throughout the trial, various assessments are conducted to monitor progress and safety. These include the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), PTSD Checklist for DSM-5 (PCL-5), and other scales to measure symptoms and overall well-being.

Secondary assessments include monitoring for adverse events, vital signs, and conducting clinical laboratory tests and electrocardiograms (ECG).

4 completion and follow-up

At the end of the 52-week period, a final evaluation is conducted to assess the long-term efficacy and safety of the treatment.

The trial is estimated to conclude by May 31, 2028.

Who Can Join the Study?

The patient must have previously participated in a study called trial number TT-TSND-201 (IMPACT-1).
The patient should be within a certain age range, which includes both young adults and middle-aged adults.
The study is open to both male and female participants.
The study includes individuals who may be considered part of a vulnerable population. This means people who might need extra care or protection.

Who Cannot Join the Study?

Individuals who do not have Post-Traumatic Stress Disorder (PTSD) cannot participate. PTSD is a mental health condition triggered by experiencing or witnessing a traumatic event.
Participants must be within the specified age range. If you are outside this age range, you cannot join the study.
Both males and females are eligible, but if you do not identify as either, you may not be able to participate.
If you belong to a vulnerable population, which means you might need special protection or care, you may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
La Nua Day Hospital Mental Health Centre	Galway	Ireland
Tallaght Adult Mental Health Service	Dublin	Ireland

Trial status

Country	Status	Recruitment Start
Ireland	Not recruiting	31.01.2024

Trial locations

Investigated drugs:

Methylone

Methylone is being studied for its potential to help people with Post-Traumatic Stress Disorder (PTSD). This trial is looking at how effective and safe methylone is when used over a long period. Participants will receive single and repeated treatments to see if it can improve PTSD symptoms.

Investigated diseases:

Post-traumatic stress disorder

Post-Traumatic Stress Disorder – This is a mental health condition that can develop after 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 disorder can lead to avoidance of situations that remind the person of the trauma. Over time, these symptoms can interfere with daily functioning and relationships. The progression of PTSD varies, with some individuals experiencing symptoms for a short period, while others may have long-lasting effects.

Trial ID:

2023-508381-16-00

Protocol code:

TSND201-PTSD-203

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Long-term Effects of Methylone for Treating PTSD in Patients

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