This open-label, non-randomised trial (n=20) will investigate the safety, feasibility, and acceptability of psilocybin-assisted psychotherapy in patients with treatment-resistant depression (TRD) who are concurrently on psychotropic medication.
Psilocybin-assisted psychotherapy will consist of pre-psilocybin psychotherapy sessions for preparation, a psilocybin dosing day, and post-dosing psychotherapy sessions for integration. Participants will receive an initial dose of 15 mg of oral psilocybin, with subsequent doses ranging from 15 mg to a maximum of 45 mg, administered in sessions supervised by trained therapists. Psychotherapy sessions will address various aspects including preparation, dosing, and integration, aiming to promote meaningful integration of the psychedelic experience and behaviour change.
The primary outcome will assess the safety of psilocybin-assisted psychotherapy, focusing on changes in vital signs and monitoring adverse events. Secondary outcomes include examining the effect on mood, quality of life, function, and well-being using various assessment scales.
Participants, aged 18 to 75, must have TRD as per DSM-5 diagnosis, failed to respond to two classes of antidepressants, and have a baseline MADRS score ≥20. Exclusion criteria include significant cardiovascular conditions, epilepsy, substance use disorder within the past 12 months, psychotic disorders, significant suicide risk, and conditions preventing rapport establishment.
The trial is conducted at St. Vincent’s Hospital in Sydney, Australia, and is anticipated to recruit participants from New South Wales. The study is funded by the Black Dog Institute, with Prof Jonathan Brett serving as the principal investigator.
Trial Details
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