MIAMI — Adding methylenedioxymethamphetamine (MDMA), also known as ecstasy, to intensive psychotherapy appears to relieve posttraumatic stress disorder (PTSD), regardless of the cause, pooled data from six phase 2 studies show. The findings were presented at the American Society of Clinical Psychopharmacology (ASCP) 2018 annual meeting.
The pooled data from the trials showed that 53% of patients with chronic PTSD whose condition was resistant to other therapies were free of PTSD symptoms after undergoing MDMA-assisted psychotherapy sessions and that this relief persisted at 12-month follow-up. The US Food and Drug Administration (FDA) recently granted breakthrough therapy designation to MDMA as an adjunct to psychotherapy for adults with PTSD.
MDMA-assisted psychotherapy consists of three nondrug preparatory sessions that last 90 minutes each. These are followed by two or three all-day (8-hour) psychotherapy sessions in which MDMA is given. The 8-hour MDMA-assisted psychotherapy sessions are spaced a month apart. Neuroimaging studies in healthy individuals have shown that MDMA decreases activity in the amygdala and increases the connectivity between the hippocampus and the amygdala.
The six trials included 107 participants with chronic PTSD. All had total score of 50 on the Clinician Administered PTSD scale (CAPS-4). Patients were randomly assigned to receive either active treatment with MDMA or placebo and psychotherapy.
The pooled data showed a significant reduction in total scores on the CAPS-4 from baseline (P < .001) among patients who received MDMA-assisted psychotherapy.
In the placebo group, which consisted of 31 patients, 23% no longer met PTSD criteria; in the MDMA-assisted group, 72 patients (53%) no longer met PTSD criteria.
In addition, MDMA-treated patients showed significant improvements in depression, as measured by the Beck Depression Inventory–II (P < .05), and sleep quality, as measured by the Pittsburgh Sleep Quality Index (P < .05).
From: American Society of Clinical Psychopharmacology (ASCP) 2018. Abstract 3001456, presented May 30, 2018.