NCT06215261

Brief 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 (1:1:1), 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2024

Shorter than P25 for phase_2

Geographic Reach
3 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 4, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

January 10, 2024

Last Update Submit

November 19, 2025

Conditions

Post Traumatic Stress Disorder

Keywords

MethyloneIMPACT-2PTSDNeuroplastogenTSND-201

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 weeks (Part A) / 12 weeks (Part B)

Secondary Outcomes (4)

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

    9 weeks (Part A) / 12 weeks (Part B)

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

    9 weeks (Part A) / 12 weeks (Part B)

  • Change from Baseline in Sheehan Disability Scale (SDS)

    9 weeks (Part A) / 12 weeks (Part B)

  • Incidence of treatment-emergent adverse events (TEAEs)

    9 weeks (Part A) / 12 weeks (Part B)

Study Arms (3)

TSND-201 Low Dose

EXPERIMENTAL

Part B only

Drug: Methylone

TSND-201 Mid Dose

EXPERIMENTAL

Part B only

Drug: Methylone

TSND-201 High Dose

EXPERIMENTAL

Part B only

Drug: Methylone

Interventions

MethyloneDRUG

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

TSND-201 High DoseTSND-201 Low DoseTSND-201 Mid Dose

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Segal Trials

Lauderhill, Florida, 33319, United States

Location

Accel Research

Maitland, Florida, 32751, United States

Location

CNS Healthcare

Orlando, Florida, 32801, United States

Location

Uptown Clinical Research

Chicago, Illinois, 60640, United States

Location

Sunstone Medical

Rockville, Maryland, 20850, United States

Location

Redbird Research LLC

Las Vegas, Nevada, 89119, United States

Location

Numinus

Draper, Utah, 84020, United States

Location

Seattle NTC

Bellevue, Washington, 98004, United States

Location

Swinburne University of Technology

Hawthorn, Victoria, 3122, Australia

Location

Ramsay Clinic Albert Road

Melbourne, Victoria, 3004, Australia

Location

Monarch Mental Health Group

Melbourne, Victoria, Australia

Location

Clerkenwell Health

London, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

methylone

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 22, 2024

Study Start

April 4, 2024

Primary Completion

September 23, 2025

Study Completion

September 23, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(8)GB(1)AU(3)