Posttraumatic stress disorder (PTSD) is a serious debilitating disorder with lifetime prevalence estimated at nearly 4% globally and over 8% in the USA (Kilpatrick et al.

These studies supported expansion into phase 3 trials and led to FDA granting Breakthrough Therapy designation for this promising treatment. MDMA-assisted psychotherapy was efficacious and well tolerated in a large sample of adults with PTSD. All doses of MDMA were well tolerated, with some expected reactions occurring at greater frequency for the active MDMA group during experimental sessions and the 7 days following. Depression symptom improvement on the BDI-II was greatest for the active group compared to the control group, although only trended towards significant group differences. After two experimental sessions, more participants in the active group (54.2%) did not meet CAPS-IV PTSD diagnostic criteria than the control group (22.6%). The between-group Cohen’s d effect size was 0.8, indicating a large treatment effect. ResultsĪfter two blinded experimental sessions, the active group had significantly greater reductions in CAPS-IV total scores from baseline than the control group. Three non-drug 90-min therapy sessions preceded the first MDMA exposure, and three to four followed each experimental session.

Active doses of MDMA (75–125 mg, n = 72) or placebo/control doses (0–40 mg, n = 31) were administered to individuals with PTSD during manualized psychotherapy sessions in two or three 8-h sessions spaced a month apart. Six randomized, double-blind, controlled clinical trials at five study sites were conducted from April 2004 to February 2017. Here we evaluate six phase 2 trials in a pooled analysis to determine the study design for phase 3 trials of MDMA-assisted psychotherapy for PTSD. Posttraumatic stress disorder is a prevalent mental health condition with substantial impact on daily functioning that lacks sufficient treatment options.

Ten fifty b phase ii