Nature medicine
June 1, 2021
Jennifer M Mitchell, Michael Bogenschutz, Alia Lilienstein et al.
965 citations
A phase 3 clinical trial tested MDMA-assisted therapy against placebo for severe PTSD. Participants received manualized therapy with either MDMA or placebo alongside preparatory and integrative sessions. At two months after the last session, the MDMA group showed a significantly greater reduction in PTSD symptoms (average 24.4-point drop on the CAPS-5 scale) compared to the placebo group (13.9-point drop), with a large effect size. Functional impairment also improved more with MDMA. No serious safety issues such as abuse potential, suicidality, or heart rhythm problems were observed. The findings suggest MDMA-assisted therapy is highly effective and safe for severe PTSD, including in people with common co-occurring conditions.
Focus (American Psychiatric Publishing)
July 1, 2023
Jennifer M Mitchell, Michael Bogenschutz, Alia Lilienstein et al.
97 citations
A phase 3 clinical trial tested MDMA-assisted therapy for severe PTSD. In 90 participants randomized to receive either MDMA or placebo alongside therapy, those receiving MDMA showed a significantly larger reduction in PTSD symptoms, with an average decrease of 24.4 points on the CAPS-5 scale compared to 13.9 points in the placebo group. Functional impairment also improved more with MDMA. No serious safety issues like abuse potential or suicidality were observed. The treatment was effective even for patients with common co-occurring conditions such as depression or substance use history. The authors conclude MDMA-assisted therapy is a safe and highly effective treatment for severe PTSD.
Journal of Affective Disorders
July 1, 2022
T. D. Hull, Matteo Malgaroli, A. Gazzaley et al.
59 citations
At-home ketamine-assisted therapy with remote monitoring produced rapid and significant improvements in depression and anxiety. Among 1247 patients, 62.8% showed at least 50% improvement on the depression scale and 62.9% on the anxiety scale, with remission rates of 32.6% and 31.3%, respectively. Deterioration was rare (0.9% for depression, 0.6% for anxiety). Three patient subpopulations emerged: those who improved steadily (79.3%), those with delayed improvement (9.3%), and a chronic group (11.4%) who were more likely to report dissociation at the fourth session. Side effects at the second session predicted delayed improvement. Only six patients discontinued early due to side effects or adverse events, indicating that screening and monitoring kept risks low.