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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.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751