MDMA-Assisted Psychotherapy Shows Promise in Treating PTSD, According to Phase III Trial

A phase III randomised trial, known as MAPP2, has demonstrated that MDMA-assisted psychotherapy can be a safe and effective treatment for post-traumatic stress disorder (PTSD) symptoms. The study published in Nature Medicine by Jennifer M. and colleagues aimed to assess the impact of MDMA-assisted therapy on patients with diverse backgrounds, a crucial aspect often overlooked in previous trials.

Trial Details:

● Participants: The trial enrolled 104 adults, with 26.9% having moderate PTSD and 73.1% severe PTSD. The participants were randomised into two groups: MDMA-assisted therapy (n=53) and placebo (n=51).

● Diversity: Approximately 34% of participants identified as a race other than white, with 26.9% identifying as Hispanic or Latino. The majority of participants were assigned female sex at birth, with a higher proportion in the placebo group.

● Safety: The trial reported seven severe treatment-emergent adverse events (TEAEs), with five occurring in the MDMA-assisted therapy group and two in the placebo group. No deaths or serious TEAEs were reported.

Key Findings:

● Symptom Improvement: Patients undergoing MDMA-assisted psychotherapy experienced a significant improvement in PTSD symptoms compared to those who received placebo alongside therapy. The improvement was measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score.

● Functional Improvement: Clinician-rated functional impairment, as measured by the Sheehan Disability Scale, also improved significantly in patients who received MDMA-assisted therapy compared to those in the placebo group.

● Diverse Patient Population: Unlike earlier studies that often included a more homogenous and affluent group of participants, MAPP2 made efforts to include patients from diverse backgrounds. This approach allowed for a more representative and inclusive study population.

Significance:

● Breakthrough Therapy Designation: The FDA granted Breakthrough Therapy Designation in 2017 for the use of MDMA-assisted therapy as an adjunct to psychotherapy in treating PTSD. The positive results from this trial could pave the way for a new drug application for MDMA-assisted therapy.

● Addressing the Root Cause: Unlike existing FDA-approved treatments for PTSD, such as SSRIs (selective serotonin reuptake inhibitors), MDMA-assisted therapy appears to address the underlying causes of the condition rather than just alleviating symptoms.

● Future Research: While the results are promising, researchers acknowledge the need for further research to assess the long-term durability of the treatment's effects. Additionally, they hope to explore the potential of MDMA and other psychedelics in treating a broader range of mental health disorders.

The study's findings offer hope for individuals struggling with PTSD, and the potential approval of MDMA-assisted therapy could represent a significant advancement in the field of mental health treatment. Further research will continue to refine our understanding of this promising therapeutic approach.

Reference:

Nature Medicine Mitchell JM, et al "MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial" Nat Med 2023; DOI: 10.1038/s41591-023-02565-4.