Psilocybin with psychotherapy efficacious and safe in bipolar II depression: JAMA

In a recent study from the Sheppard Pratt Hospital, Scott Aaronson and team explored the potential of psilocybin as a treatment for Bipolar II disorder (BDII) depressive episodes. Researchers have found in a new study that Psilocybin with psychotherapy is efficacious and safe in bipolar II depression.The findings were published in Journal of American Medical Association.

This open-label non-randomized controlled trial was conducted from April 14, 2021, to January 5, 2023 and aimed to establish the safety and efficacy of psilocybin in patients aged 18 to 65 with BDII currently experiencing difficult-to-treat depressive episodes.

The trial included 15 participants (6 male and 9 female) who met specific inclusion criteria  and administered a single dose of synthetic psilocybin (25 mg) after discontinuing psychotropic medications at least two weeks in advance. The patients underwent psychotherapy sessions during pretreatment, the dosing day, and posttreatment integration.

The primary outcome measure, the change in Montgomery-Åsberg Depression Rating Scale (MADRS) at 3 weeks posttreatment, showed promising results. All participants exhibited lower MADRS scores at week 3, with a significant mean change of -24.00 points (Cohen d = 4.08; 95% CI, -29.11 to -18.89; P < .001). Repeat measures analysis indicated consistently lower MADRS scores at all posttreatment time points, demonstrating efficacy (Cohen d = 3.39; 95% CI, -33.19 to -16.95; adjusted P < .001).

At week 3, 12 participants met the response criterion (50% decrease in MADRS), and 11 achieved remission (MADRS score ≤10). These positive outcomes persisted at the study endpoint, with 12 patients meeting both response and remission criteria. Scores on secondary measures, including Quick Inventory of Depression Symptoms-Self Rating (QIDS-SR) and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), also demonstrated improvement.

Also, safety measures assessed by the Columbia Suicide Severity Rating Scale (CSSRS) and the Young Mania Rating Scale (YMRS), showed no significant changes posttreatment compared to baseline. These findings suggest not only finds psilocybin to be effective but also safe when used in combination with psychotherapy in treating BDII depression.

Source:

Aaronson, S. T., van der Vaart, A., Miller, T., LaPratt, J., Swartz, K., Shoultz, A., Lauterbach, M., Sackeim, H. A., & Suppes, T. (2023). Single-Dose Synthetic Psilocybin With Psychotherapy for Treatment-Resistant Bipolar Type II Major Depressive Episodes. In JAMA Psychiatry. American Medical Association (AMA). https://doi.org/10.1001/jamapsychiatry.2023.4685