Psilocybin reduces depression severity, improves symptoms in bipolar II disorder
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Key takeaways:
- Participants with bipolar II disorder in a current depressive episode of more than 3 months received 25 mg psilocybin and psychotherapy.
- At 12 weeks, most participants met response and remission criteria.
A single, 25 mg dose of synthetic psilocybin along with psychotherapy was safe and effective among individuals with bipolar II disorder depression, supporting further study of psychedelics for these patients, according to research.
“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,” Scott T. Aaronson, MD, of Sheppard Pratt Health System in Baltimore, and colleagues wrote in JAMA Psychiatry. “Individuals in this study displayed strong and persistent antidepressant effects, with no signal of worsening mood instability or increased suicidality.”
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The 12-week, open-label, nonrandomized controlled trial included 15 individuals aged 18 to 65 years with bipolar II disorder, who were experiencing a depressive episode of more than 3 months and had received at least two pharmacologic treatments without sufficient benefit. Participants were required to discontinue psychotropic medications 2 weeks before receiving one 25 mg dose of synthetic psilocybin.
Therapists met with participants on the day of dosing and during three, 1-hour integration sessions after treatment, during which clinician-rated Montgomery-Åsberg Depression Rating scale (MADRS) and Quick Inventory of Depression Symptoms-Self Rating (QIDS-SR) and Quality of Life Enjoyment and Satisfaction-Short Forms were completed.
The primary measure of efficacy was a change in MADRS score from baseline to week 3, while secondary measures included MADRS scores at follow-up visits and percentage of patients meeting response and remission criteria. Safety was assessed via the Columbia Suicide Severity Rating Scale (CSSRS) and the Young Mania Rating Scale (YMRS), among other measures.
According to results, all participants had lower MADRS scores 3 weeks after treatment, with a mean decrease of 24 points (95% CI, –29.11 to –18.89, Cohen d = 4.08), which corresponded to a mean 76.3% reduction from baseline. There was not a significant difference in mean MADRS scores from weeks 1 to 12.
By week 3, 12 participants met the response criteria of at least a 50% decrease in MADRS score and 11 met the remission criteria of a MADRS score of no more than 10. At 12 weeks, 12 participants met both response criteria and remission criteria.
Researchers also reported significant reductions from baseline in QIDS-SR scores at week 1 (95% CI, –15.58 to –6.95, Cohen d = 2.26), week 3 (95% CI, –16.77 to –4.03, Cohen d = 2) and week 12 (95% CI, –19.13 to –5.67, Cohen d = 2.19).
No significant adverse effects were reported, although four participants experienced headaches the day of dosing, which resolved within 24 hours. There were no significant changes from baseline in CSSRS and YMRS scores.
“This study supports further study of the utility of psychedelics in the BDII population,” Aaronson and colleagues wrote. “Consideration should be given to whether psilocybin administration alters (increases or decreases) the high risk of substance use disorders in the population, whether the novel changes in perspective and emotional processing seen with psychedelic administration can be reliably assessed in this population, and whether such cognitive alterations are necessary or sufficient for therapeutic effects.”