A Study to Assess the Use of Methylone in the Treatment of PTSD (IMPACT-1)
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.
Detailed Description
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.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
TSND-201
experimentalOral 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.
Interventions
- MDMA150 mgvia oral• weekly• 4 doses total
Split dose strategy: 150 mg initial dose followed by 100 mg booster 90 minutes later. Administered on days 1, 8, 15, and 22.
- MDMA100 mgvia oral• weekly• 4 doses total
Booster dose administered 90 minutes after the initial 150 mg dose. Administered on days 1, 8, 15, and 22.
Placebo
placeboOral administration of identical placebo capsules once weekly for 4 weeks.
Interventions
- Placebovia oral• weekly• 4 doses total
Identical capsules to TSND-201. Administered on days 1, 8, 15, and 22.
Primary Results(1 publication)
Response Rates
≥50% improvement from baseline on CAPS-5
total score ≤11 on the CAPS-5
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| TSND-201experimental | 32 | 32(100.0%) | 1(3.1%) | 1(3.1%) | 0(0.0%) |
| Placeboplacebo | 33 | 24(72.7%) | 0(0.0%) | 0(0.0%) | 0(0.0%) |
* Safety population n=32. TEAEs: 100% (32/32). 1 severe AE and 1 serious AE reported (seizure). No discontinuations due to TEAEs.
* Safety population n=33. TEAEs: 72.7% (24/33).