Several sessions of MDMA-assisted therapy led to improvements in a diverse population of adults with moderate to severe posttraumatic stress disorder (PTSD), according to a report in Nature Medicine.
“In a historic first, to our knowledge, for psychedelic treatment studies, participants who identified as ethnically or racially diverse encompassed approximately half of the study sample,” wrote Jennifer Mitchell, Ph.D., of the University of California, San Fransico, and colleagues. “A substantial proportion of participants displayed comorbid features associated with high treatment resistance, such as major depression, multiple sources of trauma (including childhood and combat trauma), and dissociative subtype PTSD.”
Mitchell and colleagues enrolled 104 adults 18 years and older with moderate to severe PTSD—defined as a score of at least 28 on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The participants, recruited from 13 sites across the United States and Israel, included 28 individuals who identified as Hispanic/Latino and 35 individuals who identified as American Indian/Alaska Native, Asian, Black/African American, Native Hawaiian/Pacific Islander, or multiple races.
Before starting therapy, all participants received three, 90-minute therapy sessions to prepare them for the study. The participants were then randomized to receive MDMA combined with therapy or placebo combined with therapy. They completed three eight-hour dosing sessions conducted by a two-person therapy team, spaced about one month apart. During these therapy sessions, 53 participants took the assigned MDMA pill and 51 took a placebo pill.
At baseline, the average CAPS-5 score among the participants was 39. At 18 weeks (about six to eight weeks after the third dosing session), CAPS-5 scores fell by 23.7 points in the MDMA group compared with 14.8 points in the placebo group. Further, 71.2% of those in the MDMA group no longer met DSM-5 criteria for PTSD after 18 weeks, compared with 47.6% of those in the placebo group. The participants in the MDMA group also showed reductions in functional impairment, as measured by changes from baseline on the Sheehan Disability Scale.
“These findings represent the culmination of over two decades of research, and, together with MAPP1 [a previous phase 3 trial], indicate that further consideration of this treatment in individuals with moderate to severe PTSD is warranted,” Mitchell and colleagues concluded.
To read more on this topic, see the Psychiatric News article “Australia Legalizes Psychedelics for Use in Depression, PTSD Therapy.”
(Image: iStock/nirat)
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