An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD (IMPACT-2)

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])

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Drug: Methylone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 79
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: +1 (650) 382-2719; Email: alyssa@transcendtherapeutics.com

Study Locations

• Australia
  • Victoria
    • Hawthorn, Victoria, Australia, 3122
      • Swinburne University of Technology
      • Contact: Study Coordinator
    • Melbourne, Victoria, Australia, 3004
      • Ramsay Clinic Albert Road
      • Contact: Study Coordinator
    • Melbourne, Victoria, Australia
      • Monarch Mental Health Group
      • Contact: Study Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo capsules to match methylone, given orally, once a week for 3 weeks NOTE: Placebo is only in Part B
Experimental: Methylone	Drug: Methylone; Methylone capsules, given orally, once a week for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Incidence of treatment-emergent adverse events (TEAEs)	Types and rates of adverse events	Up to 9 weeks

Collaborators and Investigators

• Sponsor: Transcend Therapeutics

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: PTSD; Methylone; IMPACT-2; Neuroplastogen
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: TSND201-PTSD-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No