IMPACT-2 (Methylone for PTSD)

• Research type

  Research Study

• Full title

  An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

• IRAS ID

  1008614

• Contact name

  Amanda Jones

• Contact email

  amanda@transcendtherapeutics.com

• Sponsor organisation

  Transcend Therapeutics

• Research summary

  Methylone is a new and potentially effective treatment option for participants with post traumatic stress disorder (PTSD). This is a two-part study to evaluate the safety and efficacy of methylone for the treatment of PTSD. Part A is an open-label assessment in up to 15 participants with PTSD; Part B is a randomized (1:1), double-blind, placebo-controlled assessment in up to 64 participants. After completion of Part A, enrolment for Part B will begin.
  Eligible participants are 18 to 70 years of age with a diagnosis of PTSD. Each participant will attend a total of 17 visits, including 3 weekly dosing sessions, over the up to 13 week study period.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  23/LO/0774

• Date of REC Opinion

  27 Oct 2023

• REC opinion

  Further Information Favourable Opinion