Ptsd criteria dsm 5 bullet4/13/2024 ![]() ![]() There are a number of environmental and biological risk factors that contribute to the development and maintenance of PTSD 1, and poor PTSD treatment outcomes are associated with several comorbid conditions that include childhood trauma 2, alcohol and substance use disorders 3, depression 4, suicidal ideation 5 and dissociation 6. PTSD is a common and debilitating condition with immeasurable social and economic costs that affects the lives of hundreds of millions of people annually. 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. 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. Nature Medicine volume 27, pages 1025–1033 ( 2021) Cite this article MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study
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