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MDMA-assisted psychotherapy for severe PTSD: a randomized, double-blind, placebo-controlled, phase 3 clinical trial

The results of clinical research on the use of MDMA-assisted psychotherapy in the treatment of post-traumatic stress disorder (PTSD) encourage tremendous hope and optimism. This groundbreaking research shows impressive treatment outcomes, offering hope to people struggling with moderate to severe PTSD.

The key findings of this landmark study are as follows:

An incredibly high percentage of 86.5% of participants receiving MDMA-assisted therapy achieved clinically significant improvement in PTSD symptoms. As many as 71.2% no longer met the criteria for PTSD by the end of the study.

These results are consistent with previous pilot studies, confirming the effectiveness of MDMA-assisted psychotherapy in the treatment of PTSD, even in complex cases with comorbidities such as depression and dissociative disorders.

Particularly impressive is that the dropout rate from MDMA-assisted therapy was remarkably low, compared to other treatment approaches for PTSD. This indicates a high level of acceptability and tolerability of this therapeutic method.

The safety profile of MDMA-assisted therapy has been reconfirmed, with only transient and mild side effects, without escalating suicidality.

These remarkable results offer a new, revolutionary therapeutic option for those struggling with trauma. They represent a huge step forward in the treatment of PTSD and open the door to a transformative improvement in the quality of life of people who have survived some form of trauma.

MAPS Public Benefit Corporation ("MAPS PBC"), now Lykos Therapeutics, a clinical-stage company dedicated to changing the way mental health problems are treated, has submitted a Drug Registration Application ("NDA") to the US Food and Drug Administration ("FDA") for MDMA (capsules midoamafetin) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other support services provided by a qualified health professional. This investigational MDMA-assisted therapy is in development for people with post-traumatic stress disorder ("PTSD") and, if approved, will be the first psychedelic therapy to receive approval.

The research is available here: https://www.nature.com/articles/s41591-021-01336-3?ref=nepopularna.org#citeas

In Serbia, the use of psychedelics is illegal under the Law on Psychoactive Controlled Substances. This law prescribes the regulation and prohibition of the possession, production, distribution, marketing and use of psychoactive substances, including psychedelics. In accordance with the current legislation in Serbia, the use of psychedelics is considered illegal and is not supported by our organization.