This open-label waitlist trial (n=30) assessed the feasibility of psilocybin-assisted psychotherapy (PAP/PAT) in a complex population with treatment-resistant depression (TRD), including major depressive and bipolar II disorders, baseline suicidality, and significant comorbidity. Participants received one, two, or three sessions of PAP with psilocybin (25mg), accompanied by preparation and integration psychotherapy sessions. Immediate treatment showed greater reductions in depression severity (MADRS) compared to the waitlist period, with a large effect size (g = 1.07, p < 0.01). Repeated doses were associated with further reductions in depression severity. Adverse events were transient, and the study demonstrated feasibility, preliminary antidepressant efficacy, safety, and tolerability in this population.
- Published
- Journal
- Med
- Authors
- Rosenblat, J. D., Meshkat, S., Doyle, Z., Zumrova, A., Marlborough, M., Mcintyre, R. S., Kaczmarek, E., Brudner, R. M., Kratiuk, K., Mansur, R. B., Schulz-Quach, C., Sethi, R., Abate, A., Ali, S., Bawks, J., Blainey, M. G., Brietzke, E., Cronin, V., Danilewitz, J., Dhawan, S., Fonzo, A. D., Fonzo, M. D., Drzadzewski, P., Dunlop, W., Fiszter, H., Gomes, F. A., Grewal, S., Leon-Carlyle, M., Mccallum, M., Mofidi, N., Offman, H., Riva-Cambrin, J., Schmidt, J., Smolkin, M., Quinn, J. M.