Study of Methylone Treatment for Adults with Post-Traumatic Stress Disorder (PTSD)

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What is this study about?

This study investigates the use of methylone (TSND-201) for treating people with Post-Traumatic Stress Disorder (PTSD). PTSD is a mental health condition that can develop after experiencing or witnessing a traumatic event, causing persistent distressing memories, nightmares, and severe anxiety.

The study aims to evaluate if methylone capsules taken by mouth can help reduce PTSD symptoms. During the study, participants will receive either methylone or placebo capsules. The treatment will be given once weekly over a period of 4 weeks, followed by additional monitoring to assess the effects.

The study is divided into two parts. The first part focuses on determining if the medication is safe and how well people tolerate it. The second part examines how effective the medication is at improving PTSD symptoms. Throughout the study, participants will have their health monitored through various assessments and medical examinations to ensure their safety and evaluate their response to the treatment.

1 Initial assessment

Your diagnosis of Post-Traumatic Stress Disorder (PTSD) will be confirmed using standard diagnostic criteria

Your PTSD symptoms must be present for at least 6 months and be moderate to severe

A score assessment will be conducted using the CAPS-5 evaluation tool

2 Treatment phase – Part A

You will receive methylone capsules (50 mg) once per week for 4 weeks

The medication will be taken orally

Regular monitoring of your vital signs will occur, including heart rate, blood pressure, and temperature

Blood tests and urine analysis will be performed

Heart monitoring through ECG will be conducted

3 Assessment period – Part A

Your PTSD symptoms will be evaluated using various assessment tools

Side effects and safety aspects will be monitored

Your overall progress and well-being will be assessed

4 Treatment phase – Part B

You may receive either methylone capsules or a placebo (inactive capsule)

Treatment continues with weekly doses

Regular health monitoring continues as in Part A

5 Final evaluation

Final assessment of your PTSD symptoms will be conducted at week 10

Complete medical evaluation including blood tests, heart monitoring, and vital signs check

Assessment of overall treatment response and symptom changes

Who Can Join the Study?

Must be diagnosed with Post-Traumatic Stress Disorder (PTSD) of moderate to severe intensity that has lasted for at least 6 months. This will be confirmed by a specialist using standard diagnostic criteria.
Must score 35 or higher during initial screening and 28 or higher during baseline assessment on the CAPS-5 (a standardized test that measures PTSD symptoms).
Must have previously tried at least one treatment for PTSD (either therapy sessions or medication) that did not provide sufficient improvement.
Must be able to read and write in the local language well enough to complete study questionnaires.
Must be in generally good health without other significant medical conditions.
Must be an adult (18 years or older).
Can be either male or female.

Who Cannot Join the Study?

Current or past history of major psychiatric disorders (such as schizophrenia, bipolar disorder, or severe depression) other than PTSD
History of substance abuse or dependence within the past 6 months
Pregnant women or women who are breastfeeding
Current use of medications that could interact with the study drug (including certain antidepressants, mood stabilizers, or antipsychotics)
Severe or unstable medical conditions that could interfere with study participation
History of seizures or other neurological disorders
Liver or kidney disease
Cardiovascular conditions (heart problems, uncontrolled high blood pressure)
Previous adverse reaction to similar medications
Participation in another clinical trial within the past 30 days
Unable to provide informed consent
History of suicidal behavior or current suicidal thoughts
Inability to attend all required study visits
Active legal issues that could interfere with study completion

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	01.09.2023

Trial locations

Investigated drugs:

Methylone

Methylone is an experimental medication being studied for treating Post-Traumatic Stress Disorder (PTSD). It is taken by mouth and belongs to a class of compounds that may help reduce PTSD symptoms. The medication is being evaluated for its potential to help people who have experienced trauma and are suffering from PTSD symptoms. This trial aims to understand both how safe the medication is and whether it can effectively reduce PTSD symptoms when given over several weeks.

Investigated diseases:

Post-traumatic stress disorder

Post-Traumatic Stress Disorder (PTSD) – A mental health condition triggered by experiencing or witnessing a terrifying event. The condition develops when the natural “fight-or-flight” stress response continues long after the traumatic event has ended. People with PTSD often experience persistent, disturbing thoughts and memories of the traumatic event, along with sleep problems, feelings of detachment, and being easily startled. Symptoms typically begin within 3 months of the traumatic incident, though in some cases they may not appear until years after the event. The condition can affect daily functioning, causing difficulties in social relationships, work, and other important areas of life.

Trial ID:

2023-505874-14-00

Protocol code:

TT-TSND-201

NCT ID:

NCT05741710

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Methylone Treatment for Adults with Post-Traumatic Stress Disorder (PTSD)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?