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MAPS Shares Phase III MDMA Therapy for PTSD Results

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MDMA Treatment Significantly Less Effective for Patients on Antidepressants

MDMA-assisted therapy may not be as effective in treating post-traumatic stress disorder (PTSD) for patients who have recently used antidepressants, a new study says.

The study, published in Psychopharmacology, states that 75 percent of participants ‘met PTSD diagnostic criteria in the taper group [who still consumed serotonin reuptake inhibitors or SSRIs] compared to the non-taper group’, which was 36.4 percent of the participants.

The Multidisciplinary Association for Psychedelic Studies (MAPS) shared the results of the first of two Phase III trials of MDMA-assisted psychotherapy for treating PTSD last November, which indicated that the therapy could be an effective treatment for various forms of trauma including incidents suffered in childhood. ‘There was a 90% or greater probability that the trial, when completed, would be of sufficient size to detect statistically significant results,’ MAPS shared on its site.

The possible explanation for the reduced effectiveness of the therapy could be ‘the downregulation of binding sites (serotonin, dopamine, and/or norepinephrine) related to SSRI use; reduced MDMA treatment-relevant increases in blood pressure in patients with recent SSRI use; and/or the possibility of withdrawal symptoms from SSRIs reducing the effectiveness of MDMA-assisted therapy.’

With MDMA still in Phase III trials, the SSRIs sertraline (Zoloft) and paroxetine (Paxil) are currently the only FDA-approved medications for PTSD. However, because they are known to reduce the effects of MDMA, patients must taper off these medications prior to receiving MDMA-assisted therapy, the press release mentions.

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The author of the research, Allison A. Feduccia, says, “By determining specific factors, such as antidepressant tapering, that impact the treatment response rate of MDMA-assisted therapy, clinicians can choose approaches that maximize symptom improvements and reduce the chance that patients will require follow-up treatments.”

While MAPS is progressing gradually with its research and getting closer to obtaining a U.S Food and Drug Administration approval —most likely by 2023— the new study will encourage further research about differences in tapering. “In addition to awaiting the final results of Phase 3 clinical trials, we’ll need further research to learn more about how differences in tapering schedules or length of time on antidepressants might impact the effectiveness of this treatment,” says Veronika Gold, MFT, co-therapist on the MDMA clinical trial and co-founder of Polaris Insight Center.

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