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Mechanism5-HT2A receptor agonists [+1] |
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Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Long-Term Safety and Persistence of Effectiveness of Manualized MDMA Assisted Therapy for the Treatment of Posttraumatic Stress Disorder - Long-term follow-up of MDMA-assisted therapy for PTSD
An Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA-Assisted Psychotherapy With an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects With Posttraumatic Stress Disorder
This open-label, lead-in Phase 2 study is intended to gather supportive data on the safety and effectiveness of manualized MDMA-assisted psychotherapy as a treatment for PTSD. This will be the first study of MDMA-assisted psychotherapy in Europe using the CAPS-5 as a primary outcome measure to confirm assumptions made for statistical power calculations using the Clinician-Administered PTSD Scale for DSM-4 (CAPS-4) which support planned Phase 3 clinical trials. This study will gather supportive data on the safety and effectiveness of manualized MDMA-assisted psychotherapy as a treatment for PTSD and provide clinical supervision to planned Phase 3 therapy teams. This study will also be the first multi-site study of MDMA-assisted psychotherapy for PTSD in Europe and will explore reproducibility of findings from FDA-regulated trials in a multi-site format to further confirm the Phase 3 study design. This study will compare the effects of two open-label manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with lactose, followed 1.5 to 2 hours later by a supplemental half-dose (40 mg or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg.
100 Clinical Results associated with MAPS Europe B.V.
0 Patents (Medical) associated with MAPS Europe B.V.
100 Deals associated with MAPS Europe B.V.
100 Translational Medicine associated with MAPS Europe B.V.