This interventional trial (n=141) will investigate the potential enhancement of the antidepressant effects of psilocybin (25mg) through the addition of transcutaneous auricular Vagus Nerve Stimulation (taVNS).
The study, sponsored by Elaine Sandler and conducted at Vail Health Behavioral Health in the United States, will involve participants aged 18 to 70 with major depressive disorder (MDD).
Participants will receive a single 25 mg dose of psilocybin in a controlled therapeutic setting, followed by randomisation into three groups: one receiving taVNS, one receiving sham taVNS, and a control group receiving standard post-dosing integration sessions.
The primary aims are to evaluate the impact of taVNS on the duration and effectiveness of psilocybin’s antidepressant effects and to explore behavioural changes associated with the treatment. Assessments will include measures of depression, well-being, and social behaviour using a range of tools, including the Montgomery-Åsberg Depression Rating Scale (MADRS) and various observational methods.
The study is expected to start in February 2025 and be completed by February 2029.
Trial Details
This study will examine whether the antidepressant effect of a single dose of psilocybin administered with psychological support can be increased and extended via the use of post-dosing transcutaneous auricular Vagus Nerve Stimulation (taVNS), a known inducer of neuroplastic brain processes believed to be involved in the therapeutic effects of psilocybin. In addition, the study will examine objectively measured aspects of real-world social behavior known to promote wellbeing. Finally, the study will explore strategies for improving our ability to identify pre-treatment or early post-treatment behavioral responses to psilocybin predictive of good and bad longer-term therapeutic outcomes.NCT Number NCT06512194