This Phase II, two-part, multicentre trial (n=64) will assess methylone as a treatment for adults with post-traumatic stress disorder (PTSD). It is designed to evaluate the drug’s safety, tolerability, and efficacy in participants aged 18–65 years in the UK, including people who have previously tried at least one PTSD treatment without sufficient benefit.
This study is evaluating the safety, tolerability, and efficacy of methylone in adults with PTSD. The study will be conducted in two parts.
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.
Oral administration of methylone consisting of an initial 150 mg dose followed by a 100 mg booster dose 90 minutes later, administered once weekly for 4 weeks.
Split dose strategy: 150 mg initial dose followed by 100 mg booster 90 minutes later. Administered on days 1, 8, 15, and 22.
Booster dose administered 90 minutes after the initial 150 mg dose. Administered on days 1, 8, 15, and 22.
Oral administration of identical placebo capsules once weekly for 4 weeks.
Identical capsules to TSND-201. Administered on days 1, 8, 15, and 22.