A study, published this month in the journal JAMA Psychiatry, sought to determine whether “a single psychedelic dose of psilocybin with psychotherapy demonstrate[s] evidence for efficacy and/or safety in drug-free, treatment-resistant participants with bipolar II depression.”
The researchers conducted a 12-week, open-label nonrandomized controlled trial conducted at Sheppard Pratt Hospital involving 15 individuals with bipolar II depression, ultimately concluding that “most participants met remission criteria on the Montgomery-Åsberg Depression Rating Scale 3 weeks after a single 25-mg psilocybin dose, and most remained in remission 12 weeks postdose with no increase in mania/hypomania symptoms or suicidality.”
“The findings suggest efficacy and safety of psilocybin in bipolar II depression and support further study of psychedelics in this population,” the researchers said.
The researchers noted that, to their knowledge, their nonrandomized controlled trial marked “the first prospective and systematic, albeit noncomparator, study reporting clinical experience with psilocybin dosing and psychotherapy in a cohort of individuals with BDII currently experiencing a major depressive episode.”
“The 15 participants in this trial had well-documented treatment-resistant BDII depression of marked severity and a lengthy duration of the current depressive episode. Individuals in this study displayed strong and persistent antidepressant effects, with no signal of worsening mood instability or increased suicidality. As a first open-label foray into this underserved and treatment-resistant population, care should be taken not to overinterpret the findings. Administration of a psychedelic agent under carefully controlled and supportive conditions may yield distinct effects compared to self-report surveys on recreational use of psychedelics by people with BD,” the researchers explained.
In conclusion, they said that the findings “support further study of psychedelics in the BDII population.”
“Consideration should be given as to whether administration of psilocybin affects the high risk of substance use disorders in the BD population. It is premature to extrapolate these data to the BDI population, who are at higher risk of mania and psychosis,” they said.
Researchers continue to explore the potential of psilocybin –– the hallucinogenic compound found in psychedelic mushrooms –– to treat depression and post-traumatic stress disorder, among others.
One recent study suggested that combining traditional medication with a microdose of psilocybin could be an effective treatment for patients with ADHD.
Such encouraging findings have prompted lawmakers at the state and federal level to push for drug reform in order to make psychedelics like psilocybin accessible to patients who could benefit from the treatment.
Military veterans have been at the forefront in the push for psychedelic treatment in the United States.
A bipartisan bill introduced by a pair of Wisconsin lawmakers last month would aim to give veterans in the Badger State a path to receiving psilocybin treatment for PTSD.
The measure “would create “a new separate nonlapsible trust fund designated as the medicinal psilocybin treatment fund and establishes a pilot program to study the effects of medicinal psilocybin treatment on patients with post-traumatic stress syndrome (PTSD).”
Under the terms of the bill, the pilot program would be created by “the Board of Regents of the University of Wisconsin System at the University of Wisconsin-Madison in collaboration with that institution’s Transdisciplinary Center for Research in Psychoactive Substances and its School of Pharmacy.”
The board “must ensure that no health information disclosed in the course of conducting the program contains personally identifiable information,” and the researchers overseeing the program “must create reports for the governor and the appropriate standing committees of the legislature regarding progress of the pilot program and the studies conducted as part of the program.”
“The individuals eligible to participate in the pilot program must be veterans who are 21 years of age or older and who suffer from treatment-resistant PTSD. Individuals who are law enforcement officers are not eligible to participate in the pilot program study. The psilocybin therapy provided by the pilot program must be provided through pathways approved by the federal Food and Drug Administration, and the research accomplished in the pilot program may be accomplished in conjunction with other medications approved by the federal Food and Drug Administration,” the bill’s summary said.
The medicinal psilocybin treatment fund created by the bill would consist of “donations, gifts, grants, bequests, moneys transferred from the general fund, and all earnings and other investment income of the fund,” while the trust fund would be “managed by the State of Wisconsin Investment Board.”
One of the bill’s sponsors, Republican state Sen. Jesse James, a veteran of the Gulf War, said that Wisconsin is stepping up because Washington has failed to act.
“Our federal government has failed us when it comes to marijuana and the psilocybin and all these other variants that are out there in doing these studies,” James said last month. “So, if states have to take it upon themselves to do it, then I guess that’s what we should be doing.”
