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

Post Traumatic Stress Disorder Clinical Trial

— IMPACT-1  

Official title:

A Pilot Study to Assess the Use of Methylone in the Treatment of PTSD IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741710
• Other study ID #: TT-TSND-201
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Transcend Therapeutics
• Contact: Study Director
• Phone: 650-769-6472
• Email: amanda[@]transcendtherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

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

Locations

Country	Name	City	State
Ireland	Tallaght Adult Mental Health Services	Dublin
Ireland	La Nua Day Hospital Mental Health Centre	Galway
United Kingdom	Mirabilis Health	Belfast	Northern Ireland
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Glasgow Clinical Research Facility, QEUH	Glasgow
United Kingdom	Clerkenwell Health	London
United Kingdom	King's College	London
United Kingdom	St. Pancras Clinical Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Transcend Therapeutics

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

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	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
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 10 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 10 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 represented more disability. Total sores range from 0 to 30.	up to 10 weeks
Secondary	Incidence of treatment-emergent adverse events (TEAEs)	Type and rates of adverse events	up to 10 weeks