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AMA Study Shows Safety, Efficacy of Psilocybin in Treating Bipolar Depression

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A new clinical study from the American Medical Association (AMA) has indicated that psilocybin-assisted psychotherapy may be safe and effective in the treatment of bipolar II disorder depressive episodes. The nonrandomized controlled study was conducted at Baltimore’s Sheppard Pratt Hospital and involved 15 patients diagnosed with treatment-resistant BDII depression with lengthy depressive episodes.

After receiving a single psilocybin dose followed by seven psychotherapy sessions, researchers say study participants “displayed strong and persistent antidepressant effects” with no increase in mood instability of suicidality. Patients with bipolar II disorder (BDII) received a 25-milligram dose of psilocybin and had seven sessions with therapists that included three pretreatment sessions, an eight-hour dosing day and three integration sessions post treatment.

The study notes that the majority of the participants “remitted rapidly,” only a week after dosing, and the remission persisted during the entire study period. In addition, 12 of the participants met response and remission criteria after the 12-week study period, researchers say, indicating that their measures of treatment-resistant BDII depression fell below the minimum threshold during the study period. The researchers were especially impressed with the fact that just a single dose of psilocybin resulted in persistent remission more than three months for patients diagnosed with treatment-resistant cyclical mood disorder.

The study also notes that while the self-reported quality of life scores by the patients showed similar improvements, there were no significant changes in terms of suicide ideation metrics, mania and safety. Still, the researchers noted that additional follow-up was warranted, particularly regarding the intensity of the psychedelic experience and how it affects the drug’s efficacy.

Researchers say their findings pointed to an association between psychedelic experience intensity and clinical benefit, especially in individuals who did not derive significant clinical benefit from psilocybin administration. According to the study, the need for a “distinct psychedelic experience” for a therapeutic response to psychedelic use is still a point of contention in the nascent psychedelic research field.

Its findings reportedly contribute to the argument that the intensity of a psychedelic experience can determine the degree of long-term antidepressive effects. However, the researchers cautioned against using the findings as an endorsement for nonmedical psilocybin use. They urged the public not to overinterpret the findings and said that psilocybin taken under “carefully controlled and supportive conditions” may produce wildly different effects compared to psilocybin taken casually or recreationally.

The trial also excluded patients with a history of conditions such as psychosis, bipolar I, borderline personality disorder and delusions.

Companies such as atai Life Sciences N.V. (NASDAQ: ATAI) are also running drug-development activities involving psilocybin and other hallucinogens. Their findings are likely to document other conditions for which these substances can provide alternative treatments that are efficacious.

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