According to a recent study, MDMA may be an effective and safe treatment for MDD. Participants showed “significantly decreased” symptoms of depression eight weeks after taking two doses a month apart.
According to the British Journal of Psychiatry report that was published last month, no adverse reactions were observed amongst the 12 participants in the study.
Although prior studies on MDMA assisted therapy have shown positive results in several cases, the majority of clinical trials focused more on PTSD than depression, according to authors. In at least one clinical trial involving PTSD patients, the authors noted that those who were given MDMA showed a “significant reduction in depressives symptoms compared to placebo”.
The new study states that “this overlap indicates that the effects seen in PTSD could apply to MDD subjects.” The MDMA-AT treatment hasn’t been tested as a therapy for people with MDD.
Researchers looked at “single and recurrent MDD episodes.” They were also excluded from the study if they suffered from psychotic disorders and personality disorders.
The treatment involved the administration of MDMA twice, about four weeks apart. It also included follow-up telephone calls and three integration sessions lasting 90 minutes. In the first session, the dosage was 80-milligrams. At the second session it increased to 120-mg. Supplemental doses were offered between one-hour and an-hour-and-ahalf after the first.
Outcomes were measured through a standardized measure of depression symptoms, the Montgomery–Asberg Depression Rating Scale (MADRS), as well as the Sheehan Disability Scale (SDS), which measures functional impairment.
According to the study, scores for depression were “significantly reduced” post-treatment compared with baseline scores. Functional impairment scores “significantly declined.”
The statistically significant improvement in both depression, and impairment of function was observed.
It states that “Consistently with previous studies on MDMA-AT, we showed both statistically as well clinically significant decreases in primary and secondary outcomes measures of depression and impairment”.
According to the article, researchers also observed a “statistically and clinically meaningful reduction” in PTSD-related symptoms. However, this wasn’t one of the major goals of the research.
The authors were hesitant to make any conclusions regarding the efficacy of this drug in treating major depression disorder. However, they did say that their results warranted further study.
They wrote that “although this small uncontrolled study cannot draw conclusions on the efficacy and safety of MDMA-AT as a MDD treatment,” “the results suggest MDMA-AT’s potential for MDD therapy, which supports future controlled randomised trials.”
In terms of safety, it was concluded by the team that MDMA could be administered safely to MDD patients, if only under specific circumstances.
The report states that “with careful screening, assessments and psychotherapy during the entire study,” it has demonstrated the safe administration of MDMA-AT to MDD participants.
The study adds that “if demonstrated as effective and safe, MDMA AT could be a significant advance in the treatment for MDD,” adding, “offering a integrated approach in which the drug is administered several times in order to catalyse the psychotherapy, rather than daily, like antidepressants.”
As interest grows in the use of MDMA, other controlled substances, and psychedelics to treat mental disorders, such as PSTD, this new report has been released.
In a review of MDMA therapy for post-traumatic disorder disorder (PTSD), published last year by the Journal of Psychedelic Studies, it was found that 5 out of 6 studies “provide evidence of apparent safety and effectiveness” of the treatment. The authors were encouraged by the findings, but said that further research would be needed before MDMA therapy is widely adopted over other treatments.
The review was conducted after a U.S. Food and Drug Administration Advisory Panel recommended that an application to authorise MDMA assisted therapy be rejected. Bipartisan legislators and veteran advocates urged officials to reconsider the guidance. However, it was ultimately rejected.
In terms of other studies on psychedelics, a study conducted with military veterans attending psychedelic retreats found that psilocybin, ayahuasca, and ecstasy led to a reduction in symptoms such as PTSD, anxiety, and depression as well as an improvement of sleep and quality of life.
Early in July, the U.S. Department of Veterans Affairs’ (VA) head said he was “particularly proud of” the work of the Administration to promote research in psychedelics as a therapy. He gave the example of studies on substances like MDMA, which have shown promising early results for the treatment of mental conditions.
VA Secretary Doug Collins said the department does “some of the best research work and very specific research work,” noting that he recently visited a VA facility in New York City “discussing MDMA therapies, which have been phenomenal in working with those with PTSD and traumatic brain injuries—these other issues that we have.”
Collins’s visit to the psychedelics research center came about a month after the VA secretary met with a military veteran who’s become an advocate for psilocybin access to discuss the therapeutic potential of psychedelic medicine for the veteran community.
Collins also briefly raised the issue in a Cabinet meeting with President Donald Trump in April.
The secretary also disclosed in April that he had an “eye-opening” talk with U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. about the therapeutic potential of psychedelic medicine. Collins also said that he is open to having vouchers provided by the government to pay for psychedelic therapies for veterans receiving services from outside the VA, as Congress looks at pathways to access.
Kennedy said in June that his agency is “absolutely committed” to expanding research on the benefits of psychedelic therapy and, alongside of the head of the Food and Drug Administration (FDA), is aiming to provide legal access to such substances for military veterans “within 12 months.”
During a recent Senate committee hearing, Collins separately reiterated his commitment to exploring the efficacy of psychedelic therapy to address serious mental health conditions that commonly afflict military veterans.
Meanwhile in May, bipartisan congressional lawmakers asked the VA head to meet with them to discuss ways to provide access to psychedelic medicine for military veterans.
In a letter sent to Collins, Reps. Lou Correa (D-CA) and Jack Bergman (R-MI)—co-chairs of the Congressional Psychedelic Advancing Therapies (PATH) Caucus—said they were “encouraged by your recent remarks about the importance of pursuing research into psychedelic treatments and other alternative treatments to improve Veterans’ care.”
Correa and Bergman separately introduced a bill in April to provide $30 million in funding annually to establish psychedelics-focused “centers for excellence” at VA facilities, where veterans could receive novel treatment involving substances like psilocybin, MDMA and ibogaine.
Bergman has also expressed optimism about the prospects of advancing psychedelics reform under Trump, arguing that the administration’s efforts to cut spending and the federal workforce will give agencies “spines” to tackle such complex issues.
In December, VA separately announced that it’s providing $1.5 million in funding to study the efficacy of MDMA-assisted therapy for veterans with PTSD and alcohol use disorder (AUD).
Last year, VA’s Yehuda also touted an initial study the agency funded that produced “stunning and robust results” from its first-ever clinical trial into MDMA therapy.
Shereef Enahal, former VA Assistant Secretary of Health in January 2017, said it was “very encouraging” that Trumps choice to make Kennedy the HHS head had supported psychedelic reform. And he hoped to work with him on the issue if he stayed on for the next administration, but that didn’t pan out.
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