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Jennifer Mitchell, Michael P. Bogenschutz, Alia Lilienstein, Charlotte Harrison, Sarah E. Kleiman, Kelly S. Parker-Guilbert, Marcela Ot’alora G., Wael Garas, Casey A. Paleos, Ingmar Gorman and 28 more
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was -24.4 (s.d. 11.6) in the MDMA group and -13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation.
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Mitchell, J., Bogenschutz, M. P., Lilienstein, A., Harrison, C., Kleiman, S. E., Parker-Guilbert, K. S., G., M. O., Garas, W., Paleos, C. A., Gorman, I., Nicholas, C. R. N., Mithoefer, M. C., Carlin, S., Poulter, B., Mithoefer, A. T., Quevedo, S., Wells, G. B., Klaire, S. S., Kolk, B. A. V. D., … Doblin, R. (2021). MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine, 27(6), 1025–1033. https://doi.org/10.1038/s41591-021-01336-3
Mitchell, Jennifer, et al. "MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study." Nature Medicine, vol. 27, no. 6, 2021, pp. 1025–1033, https://doi.org/10.1038/s41591-021-01336-3.
Mitchell, Jennifer, Michael P. Bogenschutz, Alia Lilienstein, Charlotte Harrison, Sarah E. Kleiman, Kelly S. Parker-Guilbert, Marcela Ot’alora G., et al. "MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study." Nature Medicine 27, no. 6 (2021): 1025–1033. https://doi.org/10.1038/s41591-021-01336-3.
Mitchell J., Bogenschutz M. P., Lilienstein A. [и др.] MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study // Nature Medicine. — 2021. — Vol. 27, № 6. — P. 1025–1033. — URL: https://doi.org/10.1038/s41591-021-01336-3
@article{mitchell2021mdmaassisted,
title = {{MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study}},
author = {Jennifer Mitchell and Michael P. Bogenschutz and Alia Lilienstein and Charlotte Harrison and Sarah E. Kleiman and Kelly S. Parker-Guilbert and Marcela Ot’alora G. and Wael Garas and Casey A. Paleos and Ingmar Gorman and Christopher R. N. Nicholas and Michael C. Mithoefer and Shannon Carlin and Bruce Poulter and Ann T. Mithoefer and Sylvestre Quevedo and G. Beverly Wells and Sukhpreet S. Klaire and Bessel A. van der Kolk and Keren Tzarfaty and Revital Amiaz and Ray Worthy and Scott Shannon and Joshua D. Woolley and Cole J. Marta and Yevgeniy Gelfand and Emma Hapke and Simon Amar and Yair Wallach and Randall Brown and Scott Hamilton and Julie B. Wang and Allison R. Coker and Rebecca Matthews and Alberdina de Boer and Berra Yazar‐Klosinski and Amy Emerson and Rick Doblin},
journal = {Nature Medicine},
year = {2021},
volume = {27},
number = {6},
pages = {1025--1033},
doi = {10.1038/s41591-021-01336-3},
url = {https://doi.org/10.1038/s41591-021-01336-3}
}TY - JOUR AU - Mitchell, Jennifer AU - Bogenschutz, Michael P. AU - Lilienstein, Alia AU - Harrison, Charlotte AU - Kleiman, Sarah E. AU - Parker-Guilbert, Kelly S. AU - G., Marcela Ot’alora AU - Garas, Wael AU - Paleos, Casey A. AU - Gorman, Ingmar AU - Nicholas, Christopher R. N. AU - Mithoefer, Michael C. AU - Carlin, Shannon AU - Poulter, Bruce AU - Mithoefer, Ann T. AU - Quevedo, Sylvestre AU - Wells, G. Beverly AU - Klaire, Sukhpreet S. AU - Kolk, Bessel A. van der AU - Tzarfaty, Keren AU - Amiaz, Revital AU - Worthy, Ray AU - Shannon, Scott AU - Woolley, Joshua D. AU - Marta, Cole J. AU - Gelfand, Yevgeniy AU - Hapke, Emma AU - Amar, Simon AU - Wallach, Yair AU - Brown, Randall AU - Hamilton, Scott AU - Wang, Julie B. AU - Coker, Allison R. AU - Matthews, Rebecca AU - Boer, Alberdina de AU - Yazar‐Klosinski, Berra AU - Emerson, Amy AU - Doblin, Rick TI - MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study JO - Nature Medicine VL - 27 IS - 6 SP - 1025 EP - 1033 PY - 2021 DA - 2021/05/10 DO - 10.1038/s41591-021-01336-3 UR - https://doi.org/10.1038/s41591-021-01336-3 ER -
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