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])

Post-Traumatic Stress Disorder (PTSD)

Part A: Incidence and severity of TEAEs., Part A: Incidence and severity of AESIs., Part A: Change in HR, SBP, DBP and temperature, Part A: Clinically significant changes in ECG., Part A: Changes from baseline in clinical laboratory parameters (clinical chemistry, haematology and urinalysis)., Part B: Mean change from baseline to Week 10 compared with placebo in CAPS-5 total severity score.

Part A: Mean change from baseline to week 10 in CAPS-5 (total severity score assessed over 1 week), Part A: Percentage of participants having: - Treatment response, defined as a a. ≥ 10 point reduction on the CAPS-5 from baseline b. 30% improvement from baseline on CAPS-5 c. 50% improvement from baseline on CAPS-5 - Remission, defined as a score of ≤ 11 on the CAPS-5, Part A: Mean change from baseline in the following scales: - CGI-S - MADRS - SDS - PCL-5 - PGI-S - BDI-II - WEMWBS - PSQI, Part A: Percentage of participants with improvement on the following scales: - PGI-C -CGI-I, Part B: Mean change from baseline compared with placebo in the following scales: - CGI-S - MADRS - SDS - PCL-5 - PGI-S - BDI-II - WEMWBS - PSQI, Part B: Percentage of participants having: - Treatment response, defined as a a. ≥ 10 point reduction on the CAPS-5 from baseline b. 30% improvement from baseline on CAPS-5 c. 50% improvement from baseline on CAPS-5 - Remission, defined as a score of ≤ 11 on the CAPS-5 - Improvement on the PGI-C - Improvement on the CGI-I, Part B: Incidence and severity of TEAEs, Part B: Incidence and severity of AESIs, Part B: Change in HR, SBP, DBP and temperature during each dosing session, Part B: Clinically significant changes in ECG, Part B: Changes from baseline in clinical laboratory parameters (clinical chemistry, haematology, and urinalysis)

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