MDMA-Assisted Therapy Shows Significant Positive Response on Self-Experience in Patients With PTSD

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According to new research, midomafetamine capsules (MDMA) may enhance treatment efficacy by improving problems of self-experience that are associated with treatment resistance. In particular, MDMA-assisted therapy has shown significant positive response on the processes of self-experience in patients with posttraumatic stress disorder (PTSD) when compared with therapy plus placebo.¹

In a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial of participants with severe PTSD, MDMA-assisted therapy induced significant positive change in the Clinician-Administered PTSD Scale for DSM-5 when compared with therapy plus placebo. Investigators evaluated the effects of MDMA-assisted therapy and therapy plus placebo on 3 transdiagnostic outcome measures, then examined how the changes in self-experience improved PTSD scores.

Approximately 90 participants were randomized to receive manualized therapy with either MDMA or placebo (MDMA-assisted therapy, n = 46; therapy plus placebo, n = 44) during 3 experimental sessions. Of those participants, 84.4% (76/90) had history of developmental trauma and 87.8% (79/90) had suffered multiple traumas. Investigators visited participants 3 times in preparation and 9 times for integration therapy. Symptoms were measured at baseline and 2 months after the last experimental session using 3 different scales: (1) 20-item Toronto Alexithymia Scale (TAS-20); (2) the 26-item Self Compassion Scale (SCS); and (3) the 63-item Inventory of Altered Self-Capacities (IASC).

MDMA-assisted therapy generated statistically significant greater improvement on the TAS-20, the SCS, and most IASC factors of interpersonal conflicts including idealization disillusionment, abandonment concerns, identity impairment, self-awareness, susceptibility to influence, affect dysregulation, affect instability, affect skill deficit, and tension reduction activities. The only exception was identity diffusion.

As transdiagnostic mental processes of self-experience are often associated with poor treatment outcome and therapy alone may not adequately help patients with severe PTSD, MDMA-assisted therapy’s significant positive effects provide an important treatment opportunity.

“It is hypothesized that the MDMA lowers psychological defenses, increases self-confidence, increases empathy, increases trust, increases emotional learning, decreases anxiety and fear, and improves mood. The combination of MDMA with intensive therapy seems to create a safe holding environment for the patient to be more likely to allow these traumatic memories to surface and be consciously processed,” Psychiatric Times Editor-in-Chief, John J. Miller MD, wrote.²

In February 2024, the US Food and Drug Administration accepted a New Drug Application for MDMA-assisted therapy for individuals with PTSD.³ The FDA also granted priority review status to the application and set a Prescription Drug User Fee Act target action date of August 11, 2024. If approved, this will mark the first instance of MDMA-assisted therapy and psychedelic-assisted therapy.

“Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD,” said Amy Emerson, chief executive officer of Lykos Therapeutics and developer of the investigational MDMA-assisted therapy, in a press release.⁴

Stay up-to-date on news related to research on promising new interventions and developments in the treatment of a wide variety of psychiatric disorders at psychiatrictimes.com.

References

1. van der Kolk BA, Wang JB, Yehuda R, et al. Effects of MDMA-assisted therapy for PTSD on self-experience. PLoS One. 2024;19(1):e0295926.

2. Miller JJ. You have to say hello before you can say goodbye. Psychiatric Times. 2023;40(10).

3. O’Brien E. FDA accepts, grants priority review of NDA for MDMA-assisted therapy for PTSD. Psychiatric Times. February 13, 2024. https://www.psychiatrictimes.com/view/fda-accepts-grants-priority-review-of-nda-for-mdma-assisted-therapy-for-ptsd

4. Lykos Therapeutics announces FDA acceptance and priority review of New Drug Application for MDMA-assisted therapy for PTSD. Lykos Therapeutics. News release. February 9, 2024. Accessed February 13, 2024. https://news.lykospbc.com/2024-02-09-Lykos-Therapeutics-Announces-FDA-Acceptance-and-Priority-Review-of-New-Drug-Application-for-MDMA-Assisted-Therapy-for-PTSD