Science & Health
MDMA ‘Significantly Reduced’ Major Depressive Disorder Symptoms, New Research Concludes
MDMA could be a safe and effective treatment for major depressive disorder (MDD), according to a new study, with participants showing “significantly reduced” depression symptoms eight weeks after receiving two doses of the drug a month apart.
No serious adverse effects were reported among the 12 subjects in the study, says the report, published last month in the British Journal of Psychiatry.
While prior research on MDMA-assisted therapy (MDMA-AT) has shown promising results for several conditions, authors wrote, most clinical trials have focused on PTSD rather than depression. But in at least one past clinical trial involving people with PTSD, they noted, those given MDMA “showed a significant reduction in depressive symptoms compared with placebo.”
“This overlap suggests that the effects observed in PTSD may apply to subjects with MDD,” the new study says. “However, MDMA-AT therapy has not been studied as a treatment for individuals with a primary diagnosis of MDD.”
The new research looked at patients with a diagnosis of “single or recurrent episodes of MDD.” Subjects were excluded if they were pregnant or had psychotic disorders, mania, personality disorders, eating disorders with purging, substance use disorders or a host of other conditions.
Treatment involved two administrations of MDMA about four weeks apart, as well as follow-up phone calls and three 90-minute integration sessions. Dosage ranged from an 80-milligram dose at the first session to an offered 120-mg dose at the second session, with supplemental doses offered an hour to an hour and a half after the first dose.
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.
The study notes that scores of depression “were significantly reduced post treatment compared with baseline,” while functional impairment scores also “significantly decreased.”
“We observed statistically significant improvements in both depression and functional impairment.”
“Consistent with previous studies of MDMA-AT for PTSD, we demonstrated both statistically and clinically significant reductions in the primary and secondary outcome measures of depression and functional impairment,” it says.
Researchers also “observed a statistically and clinically significant reduction in PTSD symptoms,” the paper says, though that was not one one of the main aims of the study.
Authors hesitated to draw sweeping conclusions about the drug’s efficacy at treating major depressive disorder, but they said their findings warrant further research.
“Although this small, uncontrolled trial cannot draw conclusions about the efficacy of MDMA-AT for MDD,” they wrote, “the findings suggest that MDMA-AT has potential as a treatment for MDD, and supports future randomised controlled trials.”
As for safety, the team concluded that MDMA can be safely administered to patients with MDD, at least under certain circumstances.
“With careful screening, assessment and psychotherapy throughout the study,” the report says,” we demonstrated that MDMA-AT can be safely administered to participants with MDD.”
“If demonstrated to be effective and safe in RCTs, MDMA-AT could represent a significant advancement in the treatment of MDD,” it adds, “offering an integrated approach where the drug is used several times to catalyse psychotherapy rather than being administered daily as is the case with antidepressants.”
The new report comes as interest continues to grow into the potential for MDMA, psychedelics and other controlled substances to treat certain mental health conditions, including PSTD and others.
A broad review published in the Journal of Psychedelic Studies last year, for example, found that five out of six studies into MDMA for post-traumatic stress disorder (PTSD) “provide evidence for the apparent safety and efficacy” of the therapy. But while authors called the results “encouraging,” they said more robust research was needed before MDMA-assisted therapy sees widespread adoption over currently available forms of treatment.
That review came on the heels of a U.S. Food and Drug Administration (FDA) advisory panel’s recommended rejection of an application to authorize MDMA-assisted therapy. A group of bipartisan lawmakers and veterans advocates asked that officials rethink that guidance, but ultimately the rejection was made final.
As for other research into psychedelics and depression, a recent study of military veterans who attended psychedelics retreats concluded that psilocybin and ayahuasca both led to reductions in symptoms of PTSD, depression and anxiety as well as improved sleep, quality of life and post-deployment reintegration.
Meanwhile, the head of the U.S. Department of Veterans Affairs (VA) said in early July that he’s “particularly proud” of the administration’s work to promote research into psychedelics therapy, citing studies into substances like MDMA that show promising early results in the treatment of mental health 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. And Collins said he’s open to the idea of having the government provide vouchers to cover the costs of psychedelic therapy for veterans who receive services outside of VA as Congress considers pathways for 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.
In January, former VA Under Secretary for Health Shereef Elnahal said that it was “very encouraging” that Trump’s pick to have Kennedy lead HHS has supported psychedelics 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.
Photo courtesy of Pretty Drugthings on Unsplash.
