The results of a clinical trial published in the American Medical Association suggest efficacy and safe use of psilocybin assisted psychotherapy to treat bipolar II disorder. This mental illness is often associated with difficult-to-treat episodes of depression.
The authors noted that “the 15 participants in this study had a well-documented BDII depressive disorder of marked severity, and a long duration of their current episode.” The paper states that after seven sessions of psychotherapy, including one with a single dose psilocybin administered, the study subjects showed “strong and persistent antidepressant effect, without any sign of worsening of mood instability or increased suicide.”
The nonrandomized controlled trial, conducted at Sheppard Pratt Hospital, Baltimore, found that “12 patients met response and remission” criteria at the end a 12-week period of study. This means that the measures of diagnosis had fallen by more than 50% and were below a threshold.
The results of this nonrandomized open-label controlled trial indicate efficacy and safe use of psilocybin in combination with psychotherapy for BDII depression.
The study, funded by COMPASS Pathways, a biotechnology company that develops psychedelic treatment, found that patients’ self-reported scores on quality of life “demonstrated comparable improvements.” The study found that, in terms of safety metrics such as suicidal thoughts and mania did not significantly change at baseline compared to posttreatment.
The study by nine authors, published in JAMA Psychiatry on Wednesday, involved administering a 25-milligram dose psilocybin. Patients with bipolar disorder II (BDII), met with therapists at least seven times: during three pre-treatment sessions and once for an “8-hour dose day”. They also attended three integration sessions after treatment.
The report states that “in this study, most participants experienced remission quickly (i.e. within one week of dosing) and for most participants, the remission lasted throughout the 12-week study period.” The report states that “the 3 participants who stopped taking medication because of relapse or lack of benefit had a poorer response to the study.”
It continues, “Achieving persistent remission in a sample patients with treatment resistant cyclical mood disorders over a three-month period is noteworthy, especially when considering the single dose of psilocybin.” Further follow-up should be done.
“Most participants achieved remission 3 weeks after receiving a 25-mg dose of psilocybin, and most were still in remission at 12 weeks following the single dose with no increase in mania/hypomania or suicidal symptoms.”
Researchers suggested that the intensity of the psychedelic experiences may be an area that warrants further study. Researchers found “a correlation between the intensity of the overall psychedelic experiences and the clinical benefits.” Individuals who experienced little subjective effect from psilocybin showed no clinical benefit.
The study states that “the necessity of a distinct psychotic experience for response is a matter of debate in the field.” “And the findings of this research suggest that the level of psychedelic experiences are predictive of long-term antidepressant effect.”
The authors cautioned against interpreting the positive results as an endorsement for casual or unsupported use of psilocybin.
They wrote that “as this is the first open-label study of this underserved, treatment-resistant group,” it was important not to misinterpret their findings. Under carefully controlled and supportive circumstances, a psychedelic drug may have different effects than self-reports of recreational use by people with BD.
The trial excluded patients who had a history, for example, of bipolar disorder I, schizophrenia or psychosis or borderline personality disorder or substance abuse disorder in the last year.
The study states that all 15 participants “fully withdrew from all antidepressant medications and mood stabilizing medication at least two weeks before dosing.” Nine people did not restart medications during the entire study period. Six others restarted one or more medications. Some others showed mixed results. One person “remitted in week 3, relapsed in week 6, dropped out and restarted medications and was coded a nonresponder during weeks 9 and 12.” Another restarted medicine “at week 2 before the primary outcomes visit at week 3 and was considered as a responder throughout the entire study.”
The authors said that follow-up studies were needed to gauge the potential long-term effects of the treatment. They also noted that the “small sample size” of their trial limited the results.
The researchers added that the findings of their study “cannot extrapolate” to bipolar I or bipolar II patients “in a mixed phase or hypomanic stage of their illness.”
The JAMA study is part of a growing body research that shows the potential for psilocybin to treat a variety of mental conditions including PTSD and treatment-resistant depression. It also includes anxiety and substance abuse disorders.
In a recent survey, more than 1,200 Canadian patients were asked to provide their opinions on the use of psilocybin in helping people with psychological distress . Researchers found that psilocybin appeared to have “particularly strong benefits for those who experienced more severe childhood adversity.”
Researchers at Johns Hopkins University (JHU), Ohio State University (OSU) and Unlimited Sciences (US) published findings in September showing an link between psilocybin and “persistent reductions” of depression, anxiety, and alcohol abuse, as well as increased emotional regulation, spiritual wellness, and extraversion.
The authors of the study stated that these results “were highly consistent with an increasing body of clinical trials, behavioral pharmacology and epidemiological data about psilocybin.” These data are a valuable window into the current resurgence in public interest in classic psychoactives, and the results of concurrent increases in naturalistic use of psilocybin.
In August , a separate study by the American Medical Association showed that people with depression suffered a “clinically significant sustained” reduction in symptoms after only one dose of psilocybin.
A peer-reviewed article published in Nature found that patients with mild to moderate PTSD experienced a reduction in symptoms after treatment with MDMA. These results could lead the FDA to approve the substance as early as next year.
A study published in August showed that administering small doses of MDMA with psilocybin or LSD appeared to reduce feelings like guilt or fear, which are often side effects when consuming magic mushrooms or LSD.
In June, a first-of its-kind analysis revealed novel insights on the mechanisms by which psychedelic assisted therapy helps people who struggle with alcoholism.
The National Institute on Drug Abuse at the federal level has recently begun soliciting proposals to support a series research initiatives that aim to investigate how psychedelics can be used to treat addiction.
Study finds ‘No evidence’ that Medical Marijuana causes cognitive impairment in patients with chronic health problems
Image courtesy of Workman.
The post Psilocybin’s ‘Efficacy and Safety’ For Bipolar II Depression Demonstrated by American Medical Association Study first appeared on Marijuana moment.
