Results of a new clinical trial published by the American Medical Association “suggest efficacy and safety” of psilocybin-assisted psychotherapy for treatment of bipolar II disorder, a mental health condition often associated with debilitating and difficult-to-treat depressive episodes.
“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,” authors wrote. After seven psychotherapy sessions, one involving a single dose of psilocybin, the paper says, study subjects “displayed strong and persistent antidepressant effects, with no signal of worsening mood instability or increased suicidality.”
In the nonrandomized controlled study, which was conducted at Sheppard Pratt Hospital in Baltimore, “12 patients met both response and remission criteria” at the end of a 12-week study period, the trial found, meaning that measures of the diagnosis had dropped by more than half and fell below a minimum threshold.
“The findings in this open-label nonrandomized controlled trial suggest efficacy and safety of psilocybin with psychotherapy in BDII depression.”
Patients’ self-reported quality of life scores “demonstrated similar improvements,” the study, which was funded by the biotechnology company COMPASS Pathways that develops psychedelic treatments, found. In terms of safety, metrics of suicidal ideation and mania “did not change significantly at posttreatment compared to baseline.”
The nine-author study, published on Wednesday in the journal JAMA Psychiatry, involved administering a single, 25-milligram dose of psilocybin. Patients with bipolar II disorder (BDII) met with therapists seven times—during three pre-treatment sessions, once during an “8-hour dosing day” and at three post-treatment integration sessions.
“In this study, most participants remitted rapidly (ie, within 1 week of dosing), and in most participants, remission persisted for the 12-week study duration,” the report says. “The 3 participants who restarted medication due to lack of benefit or relapse following improvement generally had poorer response throughout the trial.”
“In a sample of patients with treatment-resistant cyclical mood disorder, achieving persistent remission over a 3-month period is notable, especially given the single dosing of psilocybin,” it continues. “Further follow-up is warranted.”
Hellbound and Down 