MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents
This open-label fixed-dose trial (n=10) aims to determine the safety and feasibility of MDMA-assisted psychotherapy (80-120mg) for adolescents with treatment-resistant post-traumatic stress disorder (PTSD).
Details
Open-label, single-group Phase II study (n=10) of MDMA-assisted psychotherapy for adolescents (16–17) with treatment‑resistant PTSD; two MDMA sessions (80 mg, 120 mg) embedded in a 13‑session therapy course.
Psychotherapy schedule: four 90‑minute preparation sessions; MDMA experimental medication sessions (each ~8 hours) following the 4th and 9th therapy sessions; integration sessions after each medication session (four after first, five after second); weekly assessments and follow-ups at 3 and 6 months.
Primary objective is safety and feasibility; secondary outcomes include PTSD symptom change, depression and anxiety. Key exclusions include current high suicidality, psychotic/bipolar personal or first‑degree family history, substance use disorders, and significant medical conditions.