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  • Writer's pictureAlexander Lebedev

Phase III MDMA PTSD Trial Completed: Why It Matters.



The journey to discover potent treatments for post-traumatic stress disorder (PTSD) has spanned decades and remains a pressing concern for mental health. PTSD is not just a medical term; it's a harrowing reality for countless individuals. Stemming from traumatic experiences—be it from war, personal assaults, accidents, or other distressing events—PTSD can manifest in various ways, from nightmares and flashbacks to severe anxiety and detachment from reality. Globally, millions grapple with its effects, and while we have several traditional treatments in place, their efficacy varies. Some patients find solace and recovery, but for others, these treatments barely scratch the surface of their trauma.


This is where the potential of MDMA*-assisted therapy (MDMA-AT) comes into play.

MDMA (3,4-methylenedioxymethamphetamine), often associated with its recreational use, is now being viewed under a new light in the medical community. When combined with structured therapy sessions, MDMA has shown promise in addressing the core of PTSD, offering hope to those who felt traditional treatments fell short. This innovative approach could potentially revolutionise how we understand and treat PTSD, providing a beacon of hope for many.



* MDMA (3,4-methylenedioxymethamphetamine) is a synthetic compound with stimulant and empahogentic properties. It's known for its ability to induce feelings of euphoria, heightened sensory perception, and increased empathy. In clinical settings, it's being researched for its potential therapeutic applications, particularly in the treatment of PTSD.


Why We Should Care About FDA & Phase III Trials


For a treatment to be formally authorised by the FDA, it must undergo rigorous testing, including phase III clinical trials. Before any treatment gets an approval, it has to pass a series of tests. The study we're delving into today, funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), is akin to the final exam. If MDMA therapy passes this test, it could pave the way as a new, FDA-approved method to assist those battling PTSD in the United States, Israel and (very quickly) in Europe.


How The Research Was Conducted


Study Design:

This was a multi-site, randomised, double-blind, confirmatory phase III study. In simpler terms, participants were randomly assigned to receive either the MDMA-AT or a placebo, and, theoretically speaking, neither the participants nor the researchers knew which was which.

The treatment involved three therapy sessions, each lasting 8 hours, with doses given roughly a month apart.

Trained professionals carried out the therapy following the MAPS MDMA-AT treatment guidelines and the study's protocol. You can find more details at MAPS Treatment Manual.


Participants:

A total of 104 individuals with moderate to severe PTSD took part. The group was ethnoracially diverse, with 26.9% identifying as Hispanic/Latino and 33.7% identifying as other than White.


Measurement Tools:

The primary tool used to measure PTSD severity was the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Additionally, the Sheehan Disability Scale (SDS) was used to assess functional impairment.


What The Findings Reveal


Efficacy:

The results were promising. Participants who underwent MDMA-AT experienced a significant reduction in PTSD symptoms compared to those who received the placebo.


By the conclusion of the study, 71.2% (37 out of 52) of participants undergoing MDMA-assisted therapy no longer qualified for a PTSD diagnosis according to DSM-5 criteria.

By the conclusion of the study, 71.2% (37 out of 52) of participants undergoing MDMA-assisted therapy no longer qualified for a PTSD diagnosis according to DSM-5 criteria, in comparison to 47.6% (20 out of 42) in the therapy with placebo group. Additionally, 46.2% (24 out of 52) of those in the MDMA-assisted therapy group achieved remission criteria, as opposed to 21.4% (nine out of 42) in the placebo with therapy group (as illustrated in Fig. 3).


Functional Improvement:

Beyond just symptom reduction, the MDMA-AT group also showed greater improvement in functional impairment (almost 1.6 times more compared to placebo group).



A graph showing comparison of the MDMA and placebo groups in terms of improvements.
Comparing the Effectiveness of MDMA Therapy vs. Placebo Therapy: a) symptom reductions, b) functional improvements


Response and recovery rates in the study groups: Responders (≥10-point reduction from baseline), Loss Of Diagnosis (≥10-point reduction from baseline and no longer meeting PTSD diagnostic criteria), Remission (loss of diagnosis and CAPS-5 total severity score of 11 or less)


Safety:

Eight participants experienced mild cardiac side effects, with the majority in the MDMA-AT group. Additionally, nine participants had vascular side effects, mostly mild, but one with a history of hypertension in the MDMA-AT group had moderate hypertension. The MDMA-AT group also showed temporary increases in blood pressure and pulse during sessions compared to the placebo group.


In conclusion, this phase 3 study offers a glimmer of hope for those suffering from moderate to severe PTSD. While further research is needed, the potential of MDMA-AT as a viable treatment option is becoming increasingly clear.


What are your thoughts on the potential of MDMA-assisted therapy for PTSD? Do you think alternative treatments like this could revolutionise psychiatric care?



@ Alexander Lebedev | MD PhD

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