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

Fast replyInvestigationalNo placebo
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What is this trial about?

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

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

14 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

Methylone - A synthetic stimulant compound being investigated as a potential treatment for Post-Traumatic Stress Disorder (PTSD), administered orally on a weekly basis. This substance belongs to the class of synthetic cathinones and is currently undergoing clinical trials to evaluate its safety, tolerability, and therapeutic efficacy in PTSD patients. The compound is being studied for its potential ability to modulate neurotransmitter systems involved in emotional processing and trauma response, though its exact mechanism of action in PTSD treatment is still under investigation through clinical research.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505874-14-00Protocol codeTT-TSND-201Estimated enrolment79 patientsSponsorTranscend Therapeutics Inc.

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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).