![]() A pivotal phase 3 study (MAPP1) showed that MDMA-AT was generally well tolerated and met the trial’s primary and secondary endpoints of reduced PTSD symptom severity and decreased functional impairment 12.ĭue to disparities in trauma exposure, gender-diverse and transgender individuals, ethnoracial minorities, first responders, military personnel, veterans and victims of chronic sexual abuse have a disproportionately higher risk of developing PTSD 2, 23, 24, 25, 26, 27, 28. Several phase 2 trials indicated that MDMA-AT has an acceptable risk–benefit profile in individuals with PTSD 13. MDMA, an entactogen that promotes monoamine reuptake inhibition and release (primarily by inducing conformational change of pre-synaptic transporters 14, 15, 16, 17), effectively modulates fear memory reconsolidation, enhances fear extinction and promotes openness and prosocial behavior 18, 19, 20, 21, 22. Mounting evidence supports substituted phenethylamine 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) as a treatment for PTSD 12, 13. More effective, therapeutic interventions are needed to address the immense individual, societal and economic burdens of PTSD 10, 11. Although the selective serotonin reuptake inhibitors (SSRIs) sertraline and paroxetine are FDA approved for treating PTSD, 35–47% of individuals do not respond to treatment 9. However, many individuals have persisting symptomology, and dropout rates are high 6, 7, 8. Trauma-focused psychotherapies are the gold standard treatment for PTSD. ![]() Together, these factors are associated with symptom exacerbation, treatment resistance and treatment discontinuation 3, 5. Managing PTSD is particularly complicated in individuals experiencing the dissociative subtype of PTSD, recurrent exposure to trauma and comorbidities, such as mood disorders and alcohol and substance use disorders 2, 3, 4. Post-traumatic stress disorder (PTSD) is a serious neuropsychiatric condition affecting approximately 5% of the US population each year 1. 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. ![]() Seven participants had a severe treatment emergent adverse event (TEAE) (MDMA-AT, n = 5 (9.4%) placebo with therapy, n = 2 (3.9%)). Participants were ethnoracially diverse: 28 of 104 (26.9%) identified as Hispanic/Latino, and 35 of 104 (33.7%) identified as other than White. Overall, 26.9% (28/104) of participants had moderate PTSD, and 73.1% (76/104) of participants had severe PTSD. Participants were randomized to MDMA-AT ( n = 53) or placebo with therapy ( n = 51). 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. \) boil at its normal boiling point of 78.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).
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