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Completed

NCT Number: NCT06215261

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

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

* 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).

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Swinburne University of Technology, Hawthorn, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Methylone

Drug

Methylone capsules, given orally, once a week for 3 weeks (Part A) or 4 weeks (Part B)

Primary outcomes

  1. Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score

    Time frame: 9 weeks (Part A) / 12 weeks (Part B)

    The CAPS-5 is a structured interview designed to assess PTSD symptom severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.

Secondary outcomes

  1. Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score

    Time frame: 9 weeks (Part A) / 12 weeks (Part B)

    The MADRS is a 10-item, clinician-rated scale designed to assess severity of depression. The total score ranges from 0 to 60, with a higher score indicating more severe depression.

  2. Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)

    Time frame: 9 weeks (Part A) / 12 weeks (Part B)

    The PCL-5 is a 20-item, patient-rated scale designed to measure severity of PTSD symptoms. The total score ranges from 0 to 80, with a higher score indicating more severe PTSD symptoms.

  3. Change from Baseline in Sheehan Disability Scale (SDS)

    Time frame: 9 weeks (Part A) / 12 weeks (Part B)

    The SDS is a 3-item, patient-rated scale designed to measure disability and impairment across three domains: work/school, social life, and family life/home responsibilities. Each domain is scored from 0 to 10, with higher scores representing greater disability. Total scores range from 0 to 30.

  4. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: 9 weeks (Part A) / 12 weeks (Part B)

    Types and rates of adverse events

Sponsors and collaborators

Lead sponsor

Transcend Therapeutics

Industry

Registry information

Official study 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])

Acronym: IMPACT-2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2024
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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