September 14, 2023

expert reaction to Phase 3 study of MDMA therapy for moderate to severe PTSD

Results of a phase 3 trial looking at MDMA-assisted therapy for moderate to severe PTSD have been published in Nature Medicine.

Dr James Rucker, Senior Clinical Lecturer in psychopharmacology and mood disorders at King’s College London, said:

“This is the second phase 3 clinical trial of MDMA therapy for severe PTSD and, similar to the previous trial, shows credible and clinically significant results suggesting that this intervention is both effective and relatively safe in this patient group. It is reassuring to see that the trial team have made efforts to recruit a more ethnically diverse group of people and that the effect seems to be consistent across ethnic groups. However ethnicity is only one form of diversity and other marginalised groups may be under-represented here, a problem that tends to occur in many clinical trials.

“Whilst encouraging evidence is accumulating to support the licensing and wider adoption of MDMA therapy for PTSD, the numbers of participants in trials so far are not large enough to detect rarer side effects. In part, this is because MDMA is classified as a Schedule 1 drug, which needlessly drives up the costs of MDMA clinical trials, which in turn reduces the number of participants that can be recruited. The overall effect is that patients have to wait longer for new treatments based on Schedule 1 drugs to be developed, a scenario also seen with the ongoing development of psilocybin for major depression.”

Prof Neil Greenberg from the Royal College of Psychiatrists said:

“We’ve been eagerly awaiting the results of this important trial. The results show MDMA assisted psychotherapy appears to be effective in treating people who have chronic PTSD. It is notable that the average duration of PTSD in this study was 16 years and participants had received multiple ineffective treatments in the past. It is also important to recognise that nearly half of the participants had taken MDMA previously before taking part in this trial, which is probably not the case for most people who develop PTSD.

“This is an important trial which provides evidence of a potentially beneficial treatment option for those who cannot be helped by more traditional evidence-based treatments which thankfully help the majority of people with PTSD to recover. However, MDMA assisted psychotherapy is not going to be a treatment of choice for most patients with PTSD. The use of MDMA is likely to be tightly controlled, requires two therapists who have been trained in how to deliver psychotherapy for patients who have been given prescribed MDMA who will need to deliver the therapy in a safe, clinical location.”

‘MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial’ by Jennifer M. Mitchell et al. will be published in Nature Medicine at 16:00 UK time on Thursday 14^th September.

DOI: 10.1038/s41591-023-02565-4

Declared interests

Dr James Rucker:

Salary Funding

1. NHS (South London & Maudsley NHS Foundation Trust) and higher education (King’s College London)

Disclosures & Conflicts of Interest

1. Paid advisory boards for Clerkenwell Health (Past), Beckley PsyTech (Past), Delica Therapeutics (Past)
2. Paid articles for Janssen
3. Assistance for attendance at conferences from Compass Pathways (past) and Janssen
4. Grant funding (received and managed by King’s College London) from Compass Pathfinder, Beckley PsyTech, Multidisciplinary Association for Psychedelic Studies, National Institute for Health Research, Wellcome Trust, Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust.
5. No shareholdings in pharmaceutical companies
6. No shareholdings in companies developing psychedelics
7. Currently Principle Investigator on a clinical trial of MDMA therapy for PTSD, Sponsored and Funded by the Multidisciplinary Association for Psychedelic Studies

Prof Neil Greenberg: No declarations

For all other experts, no reply to our request for DOIs was received.