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Jennifer Mitchell, Marcela Ot’alora G., Bessel A. van der Kolk, Scott Shannon, Michael P. Bogenschutz, Yevgeniy Gelfand, Casey A. Paleos, Christopher R. N. Nicholas, Sylvestre Quevedo, Brooke Balliett and 24 more
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 < 0.001, d = 0.7). LS mean change in SDS score (95% CI) was -3.3 (-4.03, -2.60) for MDMA-AT versus -2.1 (-2.89, -1.33) for placebo with therapy (P = 0.03, d = 0.4). Seven participants had a severe treatment emergent adverse event (TEAE) (MDMA-AT, n = 5 (9.4%); placebo with therapy, n = 2 (3.9%)). There were no deaths or serious TEAEs. These data suggest that MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well tolerated. ClinicalTrials.gov identifier: NCT04077437 .
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Mitchell, J., G., M. O., Kolk, B. A. V. D., Shannon, S., Bogenschutz, M. P., Gelfand, Y., Paleos, C. A., Nicholas, C. R. N., Quevedo, S., Balliett, B., Hamilton, S., Mithoefer, M. C., Kleiman, S. E., Parker-Guilbert, K. S., Tzarfaty, K., Harrison, C., Boer, A. D., Doblin, R., Yazar-Klosinski, B., … Emerson, A. (2023). MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nature Medicine, 29(10), 2473–2480. https://doi.org/10.1038/s41591-023-02565-4
Mitchell, Jennifer, et al. "MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial." Nature Medicine, vol. 29, no. 10, 2023, pp. 2473–2480, https://doi.org/10.1038/s41591-023-02565-4.
Mitchell, Jennifer, Marcela Ot’alora G., Bessel A. van der Kolk, Scott Shannon, Michael P. Bogenschutz, Yevgeniy Gelfand, Casey A. Paleos, et al. "MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial." Nature Medicine 29, no. 10 (2023): 2473–2480. https://doi.org/10.1038/s41591-023-02565-4.
Mitchell J., G. M. O., Kolk B. A. V. D. [и др.] MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial // Nature Medicine. — 2023. — Vol. 29, № 10. — P. 2473–2480. — URL: https://doi.org/10.1038/s41591-023-02565-4
@article{mitchell2023mdmaassisted,
title = {{MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial}},
author = {Jennifer Mitchell and Marcela Ot’alora G. and Bessel A. van der Kolk and Scott Shannon and Michael P. Bogenschutz and Yevgeniy Gelfand and Casey A. Paleos and Christopher R. N. Nicholas and Sylvestre Quevedo and Brooke Balliett and Scott Hamilton and Michael C. Mithoefer and Sarah E. Kleiman and Kelly S. Parker-Guilbert and Keren Tzarfaty and Charlotte Harrison and Alberdina de Boer and Rick Doblin and Berra Yazar-Klosinski and MAPP2 Study Collaborator Group and Charlotte Harrison and Berra Yazar-Klosinski and Wael Garas and Darrick May and Cole J. Marta and Susan Walker and Elizabeth M. Nielson and G. Beverly Wells and Randall Brown and Revital Amiaz and Yair Wallach and Ray Worthy and Alia Lilienstein and Amy Emerson},
journal = {Nature Medicine},
year = {2023},
volume = {29},
number = {10},
pages = {2473--2480},
doi = {10.1038/s41591-023-02565-4},
url = {https://doi.org/10.1038/s41591-023-02565-4}
}TY - JOUR AU - Mitchell, Jennifer AU - G., Marcela Ot’alora AU - Kolk, Bessel A. van der AU - Shannon, Scott AU - Bogenschutz, Michael P. AU - Gelfand, Yevgeniy AU - Paleos, Casey A. AU - Nicholas, Christopher R. N. AU - Quevedo, Sylvestre AU - Balliett, Brooke AU - Hamilton, Scott AU - Mithoefer, Michael C. AU - Kleiman, Sarah E. AU - Parker-Guilbert, Kelly S. AU - Tzarfaty, Keren AU - Harrison, Charlotte AU - Boer, Alberdina de AU - Doblin, Rick AU - Yazar-Klosinski, Berra AU - MAPP2 Study Collaborator Group AU - Harrison, Charlotte AU - Yazar-Klosinski, Berra AU - Garas, Wael AU - May, Darrick AU - Marta, Cole J. AU - Walker, Susan AU - Nielson, Elizabeth M. AU - Wells, G. Beverly AU - Brown, Randall AU - Amiaz, Revital AU - Wallach, Yair AU - Worthy, Ray AU - Lilienstein, Alia AU - Emerson, Amy TI - MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial JO - Nature Medicine VL - 29 IS - 10 SP - 2473 EP - 2480 PY - 2023 DA - 2023/09/14 DO - 10.1038/s41591-023-02565-4 UR - https://doi.org/10.1038/s41591-023-02565-4 ER -
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