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

Post Traumatic Stress Disorder Clinical Trial

— IMPACT-2  

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])

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06215261
• Other study ID #: TSND201-PTSD-202
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Transcend Therapeutics
• Contact: Study Director
• Phone: +1 (650) 382-2719
• Email: alyssa[@]transcendtherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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), double-blind, placebo-controlled and will enroll up to 64 participants with PTSD Eligible participants will enter a 3-week Treatment Period where they will receive methylone (or placebo in Part B) once weekly for 3 weeks (3 treatment sessions). Following the Treatment Period, participants will enter a 6-week Follow-up Period.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 79
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months.
• CAPS-5 score of at least 35 at Screening.
• Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
• Proficient in reading and writing in local language sufficient to complete questionnaires.
• Free for 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.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Methylone
Methylone capsules, given orally, once a week for 3 weeks
• Placebo
Placebo capsules to match methylone, given orally, once a week for 3 weeks NOTE: Placebo is only in Part B

Locations

Country	Name	City	State
Australia	Swinburne University of Technology	Hawthorn	Victoria
Australia	Monarch Mental Health Group	Melbourne	Victoria
Australia	Ramsay Clinic Albert Road	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Transcend Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score	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.	Up to 9 weeks
Secondary	Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score	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.	Up to 9 weeks
Secondary	Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)	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.	Up to 9 weeks
Secondary	Change from Baseline in Sheehan Disability Scale (SDS)	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.	Up to 9 weeks
Secondary	Incidence of treatment-emergent adverse events (TEAEs)	Types and rates of adverse events	Up to 9 weeks