Outcomes
ideation, death, congenital anomaly, birth defect, TEAEs, PTSD, impairment or damage, disability or incapacity, Suicidality
ADVERSE EVENTS, EVENT, SECONDARY, ADVERSE EVENT, EVENTS
Independent assessors conducted CAPS-5 and SDS outcome assessments at baseline, after experimental sessions 1 and 2 and 6–8 weeks after experimental session 3 (18 weeks after baseline) via video interviews. Primary and secondary objectives were mean change in CAPS-5 total severity and SDS scores, respectively, for MDMA-AT versus placebo with therapy from baseline to 18 weeks after baseline.Exploratory outcome measurements included characterization of the treatment response and differences between the treatment groups by demographics and characteristics. Responder analyses were based on categorical diagnostic assessment data and the CAPS-5 total severity score assessment. PTSD severity was defined using the CAPS-5 total severity score as follows: asymptomatic (0–10), mild (11–22), moderate (23–34), severe (35–46) and extreme (47+) (ref. Safety objectives included assessment of differences between groups in severity, incidence and frequency of TEAEs, serious TEAEs, TEAESIs, suicidal ideation and behavior and vital signs. TEAEs were defined as any adverse event that occurred during the treatment period from the first experimental session to the last integration session. The severity of TEAEs was determined by the site physician as mild (no limitation in normal daily activity), moderate (some limitation in normal daily activity) or severe (unable to perform normal daily activity). A serious TEAE was defined as any unforeseen medical event at any dose of the drug that resulted in death; was life-threatening; required inpatient hospitalization; caused significant disability or incapacity; resulted in a congenital anomaly or birth defect; or required intervention to prevent permanent impairment or damage. Serious TEAEs also included any event, based on medical judgement, that jeopardized the participant or may have required intervention to prevent one of the events listed previously. With the exception of serious adverse event reporting, relatedness to study drug was not assessed by investigators, to preserve blinding. In an effort to identify common adverse events that may be most related to MDMA, TEAEs occurring with incidence >10% and at least twice the prevalence in the MDMA-AT group versus the placebo with therapy group are reported. Suicidality was tracked at each study visit using the C-SSRS (see the 