학술논문
MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial
Document Type
article
Author
Mitchell, Jennifer M; Ot’alora G., Marcela; van der Kolk, Bessel; Shannon, Scott; Bogenschutz, Michael; Gelfand, Yevgeniy; Paleos, Casey; Nicholas, Christopher R; Quevedo, Sylvestre; Balliett, Brooke; Hamilton, Scott; Mithoefer, Michael; Kleiman, Sarah; Parker-Guilbert, Kelly; Tzarfaty, Keren; Harrison, Charlotte; de Boer, Alberdina; Doblin, Rick; Yazar-Klosinski, Berra
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Abstract
This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) versus placebo with identical therapy in participants with moderate to severe post-traumatic stress disorder (PTSD). Changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score (primary endpoint) and Sheehan Disability Scale (SDS) functional impairment score (key secondary endpoint) were assessed by blinded independent assessors. Participants were randomized to MDMA-AT (n = 53) or placebo with therapy (n = 51). Overall, 26.9% (28/104) of participants had moderate PTSD, and 73.1% (76/104) of participants had severe PTSD. Participants were ethnoracially diverse: 28 of 104 (26.9%) identified as Hispanic/Latino, and 35 of 104 (33.7%) identified as other than White. Least squares (LS) mean change in CAPS-5 score (95% confidence interval (CI)) was -23.7 (-26.94, -20.44) for MDMA-AT versus -14.8 (-18.28, -11.28) for placebo with therapy (P