Grant: Project Grant

Lay Abstract: Bipolar II Disorder (BD II) is a lifelong condition characterized by mood fluctuations called hypomanic and depressive episodes. BD affects approximately 1 in 100 people worldwide and has a significant impact on both the personal lives of patients and society. The rate of death by suicide among patients with BD II is higher than of the general population and suicide attempts most commonly occur during depressive phases. Depression is responsible for most of the disability experienced by BD II patients who spend a great amount of time in this phase. However, only few medications are available for treatment of the depressive phases of BD II. Thus, developing new treatments that are effective and have a good safety profile is an urgent unmet need for people with BD II. Psychedelics, particularly psilocybin have acquired significant research interest due to their effects on mood and new learning, and have been associated with improvements in depression in conjunction with therapy. Considering the above, our objective is to test psilocybin as a treatment for the depressive phases of BD II in a study design known as a randomized clinical trial. In this study, participants will be randomly allocated to two groups, one will receive capsules containing full dose (25 mg) of psilocybin, and the other will receive capsules containing lower dose or micro dose of psilocybin (1 mg) at baseline in conjunction with therapy. This will allow us to determine if improvement in depression is greater in the full dose group vs micro dose group.