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Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD
This open-label, lead-in Phase II study is intended to gather data on the safety and effectiveness of manualized MDMA-assisted psychotherapy as a treatment for PTSD. This is the first multi-site study of MDMA-assisted psychotherapy for PTSD in Europe and explores the reproducibility of findings from FDA-regulated trials. The trial is being funded by the non-profit organization MAPS that received FDA “Breakthrough Therapy” designation in 2017 for the program of MDMA-assisted psychotherapy for PTSD.
For more information about MAPS and the MDMA-assisted psychotherapy research program, you can visit their internet sites:
The trial is approved by the German Federal Institute for Drugs and Medical Devices (BfArM) and the Ethics Committee of LAGeSo (Landesamt für Gesundheit und Soziales Berlin).
For more information on this trial, you can contact us at mdma(at)charite.de.