Results showed that compared to therapy with placebo, MDMA-assisted therapy participants had a statistically significant greater improvement in all self-experience measures.
PLOS ONE has published the first comparison of the effects of investigational MDMA-assisted therapy and therapy with placebo on emotional coping skills and self-experience in adults with severe post-traumatic stress disorder (PTSD).
The study explores how changes in self-experience impacted PTSD scores in Lykos Therapeutics’ Phase 3, randomized, double-blind, placebo-controlled study – MAPP1 – previously published in Nature Medicine.
Results showed that compared to therapy with placebo, MDMA-assisted therapy participants had a statistically significant greater improvement in all self-experience measures.
“People who have histories of having been traumatized as children within their caregiving systems are particularly prone to developing major deficits in emotion regulation and often develop a self-identity of being worthless and defective,” said Bessel van der Kolk, M.D., Phase 3 investigator, president of the Trauma Research Foundation and author of “The Body Keeps the Score.” “When these people are being treated for their PTSD, their lack of a sense of safety and difficulties with trust can be major obstacles to successful completion of treatment; these deficits often prevent treatment from being successful. In this study, we observed that MDMA-assisted therapy was more effective than psychotherapy alone in improving a range of problems with self-experience that are associated with treatment failure.”
Lykos, formerly known as MAPS Public Benefit Corp., has completed two Phase 3 trials for PTSD and recently submitted a new-drug application to the U.S. Food and Drug Administration for MDMA used in combination with psychological intervention and other supportive services provided by a qualified healthcare provider.
If approved by the FDA, investigational MDMA-assisted therapy would be the first psychedelic-assisted therapy approved for PTSD.
A First-Line Treatment for PTSD
Trauma-focused talk therapy is considered a first-line treatment for PTSD. However, studies have shown that several factors are limiting the success rates.
At least a quarter of patients drop out of treatment, up to half are left with lingering symptoms, and even those who respond to treatment often experience lingering challenges with emotional regulation, impulse control and interpersonal functioning, according to studies cited by Lykos.
As multiple studies have shown that reduced self-capacities interfere with successful completion of talk therapy for PTSD, the goal of the Lykos analysis was to assess if MDMA-assisted therapy or therapy with placebo had a significant impact on validated measures of self-experience, the company noted.
Study Results
The study, titled “Effects of MDMA-Assisted Therapy for PTSD on Self-Experience,” reports results from three transdiagnostic outcome measures from the company’s MAPP1 Phase 3 study, which compared the safety and efficacy of investigational MDMA-assisted therapy to therapy with placebo in participants with severe PTSD.
The analysis included 82 of 90 participants with data on self-experience measures who were randomized and completed at least one investigational treatment session.
The majority of participants were women (64.6%), white (80.3%), non-Hispanic or Latino (92.7%) and college graduates (69.5%). Among 82 participants, the mean age was 41.42 years.
Sixty-nine of 82 participants had histories of developmental trauma (such as childhood physical/sexual abuse) and 74 of 82 participants had suffered multiple traumas.
Therapy was conducted in accordance with the MDMA-assisted therapy treatment manual, Lykos noted.
Using three validated, self-reported measures – the Inventory of Altered Self Capacities, the Toronto Alexithymia Scale and the Self-Compassion Scale – the study results suggest that investigational MDMA-assisted therapy had a stronger effect on measures of emotional regulation and self-experience and statistically significant greater improvements for almost all self-experience measures compared to the therapy with placebo group.
Participants in the MDMA-assisted therapy group also had greater improvements on alexithymia (being in touch with oneself), self-compassion and most other factors of self-experience than participants in the placebo group.
“In studies of healthy volunteers, MDMA has been associated with feelings of emotional communion, oneness and relatedness, but it is important to assess if those results translate to patients with PTSD,” said Amy Emerson, chief executive officer of Lykos Therapeutics. “This is the first analysis to show that the effects of MDMA on self-experience and compassion are seen in patients with PTSD when administered in conjunction with therapy.”