and R.B., received funding from MAPS PBC during the conduct of the study for this study as well as other studies. received support as contractors of MAPS PBC for their contributions to this study and other work and study investigators and researchers, J.M.M., M.B., M.O.G., W.G., C.P., I.G., C.N., B.P., S.Q., G.W., S.S.K., B.V.D.K., K.T., R.A., R.W., S.S., J.D.W., C.M., Y.G., E.H., S.A., Y.W. received support as contractors from MAPS PBC for training and supervision of research psychotherapists for this study and other work S.K., K.P.-G. received salary support for full-time employment with MAPS for this study and other work M.M., A.M., M.O.G., B.P. received salary support for full-time employment with MAPS PBC for this study and other work A.L., B.Y.-K. The authors declare the following financial competing interests: A.E., R.M., C.H., A.D.B., S.C., A.C. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation. 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. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. The mean change in CAPS-5 scores in participants completing treatment was -24.4 (s.d. 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). Adverse events and suicidality were tracked throughout the study. 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. 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.
#Nicholas dew sc trial
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. Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. 27 Department of Neurology, University of California San Francisco, San Francisco, CA, USA.26 Stanford School of Medicine, Stanford, CA, USA.25 Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel.24 Dr Simon Amar Inc., Montreal, Quebec, Canada.23 University of Toronto, Toronto, Ontario, Canada.22 Zen Therapeutic Solutions, Mt Pleasant, SC, USA.21 New School Research LLC, North Hollywood, CA, USA.20 Wholeness Center, Fort Collins, CO, USA.19 Ray Worthy Psychiatry LLC, New Orleans, LA, USA.18 Chaim Sheba Medical Center, Tel HaShomer, Israel.17 Boston University School of Medicine, Boston, MA, USA.16 British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada.15 San Francisco Insight and Integration Center, San Francisco, CA, USA.
14 Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA.13 Medical University of South Carolina, Charleston, SC, USA.12 Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.10 Nautilus Sanctuary, New York, NY, USA.9 MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA.8 Aguazul-Bluewater Inc., Boulder, CO, USA.7 KPG Psychological Services LLC, Brunswick, ME, USA.6 Kleiman Consulting and Psychological Services, Sayreville, NJ, USA.
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