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CompletedPhase 2

An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD

Key facts

Who runs it
Transcend Therapeutics
Where
Bellevue, Chicago, Draper, Las Vegas, Lauderhill, Maitland, Orlando, and Rockville, United StatesSee the 8 sitesAlso in 2 other countries, 4 sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
62 people enrolled
Started
4 Apr 2024
Ended
23 Sept 2025
Type of study
Interventional, 3 groups
Treatments tested
  • Methylone
Record updated
30 October 2026

Who can take part

Age
18 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months
  • Tried at least one treatment for PTSD (either psychotherapy or pharmacological treatment)
  • Proficient in reading and writing in local language sufficient to complete questionnaires
  • Free from any other clinically significant illness or disease

Who cannot take part

  • Use of prohibited concomitant medications or therapies
  • Current or previous history of clinically significant cardiovascular/cerebrovascular conditions
  • Primary diagnosis of any other DSM-5 disorder
  • Uncontrolled hypertension at Screening
  • Body mass index (BMI) <18kg/m2 or ≥40 kg/m2
  • Smokes an average of >10 cigarettes and/or e-cigarettes per day

Where in United States

Also in 2 other countries, 4 sites

  • Seattle NTCBellevue, United States
  • Uptown Clinical ResearchChicago, United States
  • NuminusDraper, United States
  • Redbird Research, LLCLas Vegas, United States
  • Segal TrialsLauderhill, United States
  • Accel ResearchMaitland, United States
  • CNS HealthcareOrlando, United States
  • Sunstone MedicalRockville, United States

About the trial

What the trial wants to find out

This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts.

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* Part A is open-label and will enroll up to 15 participants with PTSD * Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD

Eligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).

The 3 groups in the trial

  • TSND-201 Low DoseTreatment being tested

    Part B only

    Treatment: Methylone

  • TSND-201 Mid DoseTreatment being tested

    Part B only

    Treatment: Methylone

  • TSND-201 High DoseTreatment being tested

    Part B only

    Treatment: Methylone

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
Record updated
30 October 2026