An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD
- Registration Number
- NCT06237426
- Lead Sponsor
- Transcend Therapeutics
- Brief Summary
This is an extension study of participants who previously completed a Transcend-sponsored clinical trial evaluating TSND-201 as a treatment for PTSD.
Participants will be followed for up to 52 weeks. During the 52 week period, PTSD symptoms and safety will be assessed monthly.
Participants' PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met, participants may be eligible to receive a course of TSND-201 treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 150
- Participation in and successful completion of a prior Transcend-sponsored clinical trial with TSND-201.
- Agree to not participate in any other interventional clinical trials for the duration of this study.
- Willing and able to provide informed consent.
- Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation.
- Change or development of any physical or psychological finding that would make participant unsuitable for study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (Methylone) Methylone -
- Primary Outcome Measures
Name Time Method Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score Up to 52 weeks 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.
- Secondary Outcome Measures
Name Time Method Incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and treatment-emergent adverse events (TEAEs) Up to 52 weeks Types and rates of adverse events
Trial Locations
- Locations (9)
Mountain View Clinical Research
🇺🇸Denver, Colorado, United States
Sunstone Medical
🇺🇸Rockville, Maryland, United States
Cedar Clinical Research, Inc
🇺🇸Draper, Utah, United States
La Nua Mental Health Centre
🇮🇪Galway, Ireland
Cambridgeshire and Peterborough NHS Foundation Trust
🇬🇧Cambridge, England, United Kingdom
NHS Greater Glasgow and Clyde
🇬🇧Glasgow, Scotland, United Kingdom
Kings College
🇬🇧London, United Kingdom
Mirabilis Health
🇬🇧Belfast, Northern Ireland, United Kingdom
Clerkenwell Health
🇬🇧London, United Kingdom