A Study to Assess the Use of Methylone in the Treatment of PTSD

NCT05741710 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: TT-TSND-201
• Study Type: interventional
• Target: 79
• Locations: 3 countries
• Sites: 16

Brief Summary

This study is evaluating the safety, tolerability, and efficacy of methylone in adults with PTSD. The study will be 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 4-week Treatment Period where they will receive methylone once weekly for 4 weeks (4 treatment sessions). Following the Treatment Period, participants will enter a 6-week Follow-up Period which includes 3 reflection visits (Week 4, 5, and 6) and a final study visit at Week 10.

Conditions

Post Traumatic Stress Disorder

Keywords

methylone; PTSD; IMPACT-1; Transcend Therapeutics

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in CAPS-5 Total Severity Score

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

  up to 10 weeks

Study Arms (2)

Methylone

EXPERIMENTAL

Drug: Methylone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Methylone DRUG

Methylone capsules, given orally, once a week for 4 weeks

Methylone

Placebo DRUG

Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months
• CAPS-5 score of ≥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 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) \<18 kg/m2 or ≥40 kg/m2.
• Smokes an average of \>10 cigarettes and/or e-cigarettes per day
• Uncontrolled hypertension at Screening
• Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as MDMA, within 12 months of Screening.
• Use of an SSRI or other antidepressant within 8 weeks of screening.
• Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.

Sponsors & Collaborators

• Transcend Therapeutics: lead

Study Sites (16)

Mountain View Clinical Research

Denver, Colorado, 80209, United States

Location

Clinical Neuroscience Solutions - Jacksonville

Jacksonville, Florida, 32256, United States

Location

Accel Research Sites

Maitland, Florida, 32751, United States

Location

Sunstone Therapies

Rockville, Maryland, 20850, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Cenexel HRI

Berlin, New Jersey, 08009, United States

Location

The Rivus Wellness & Research Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Cedar Clinical Research

Murray, Utah, 84107, United States

Location

Tallaght Adult Mental Health Services

Dublin, Ireland

Location

La Nua Day Hospital Mental Health Centre

Galway, Ireland

Location

Mirabilis Health

Belfast, Northern Ireland, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

Glasgow Clinical Research Facility, QEUH

Glasgow, United Kingdom

Location

Clerkenwell Health

London, United Kingdom

Location

King's College

London, United Kingdom

Location

Oxford Health NHS Foundation Trust

Oxford, United Kingdom

Location

Related Publications (2)

• Jones A,Warner-Schmidt J,Kwak H,Stogniew M,Mandell B,Ching THW,Stein MB,Kelmendi B

  RESULT

• Jones A, Warner-Schmidt J, Kwak H, Stogniew M, Mandell B, Ching THW, Stein MB, Kelmendi B. Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Feb 18:e254625. doi: 10.1001/jamapsychiatry.2025.4625. Online ahead of print.

  PMID: 41706459 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

methylone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Amanda Jones
• Organization: Transcend Therapeutics

amanda@transcendtherapeutics.com

9199238150

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: February 13, 2023
• First Posted: February 23, 2023
• Study Start: March 1, 2023
• Primary Completion: February 19, 2025
• Study Completion: February 19, 2025
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (2); GB (6); US (8)