Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Fast replyInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

4 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

Methylone – Methylone is administered orally in capsule form and is currently being evaluated in clinical trials for its potential use in treating Post-Traumatic Stress Disorder (PTSD). It is not yet approved for medical use, but ongoing studies aim to assess its long-term efficacy and safety. Methylone is primarily indicated for PTSD, where it may help alleviate symptoms by influencing neurotransmitter activity in the brain. It belongs to the class of psychoactive substances known as empathogens, which are thought to enhance emotional communication and reduce anxiety by increasing the release of serotonin and dopamine.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508381-16-00Protocol codeTSND201-PTSD-203Estimated enrolment150 patientsSponsorTranscend Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).