This single-arm study (n=20) investigates the safety, feasibility, and acceptability of psilocybin-assisted psychotherapy in patients with treatment-resistant depression (TRD).
The trial involves participants aged 18 to 75 who have failed to respond to two different classes of antidepressant medication treatment. The intervention consists of psilocybin-assisted psychotherapy, including pre-dosing psychotherapy sessions for preparation, a dosing day, and post-dosing integration sessions.
Participants will receive an initial dose of a 15 mg oral capsule of psilocybin, with subsequent doses ranging from 15 mg to a maximum of 45 mg, supervised by trained therapists over 7-8 hours. The study evaluates safety through changes in vital signs and adverse events, with follow-up assessments at 3 months post-psilocybin dosing. Feasibility is assessed through study enrolment/withdrawal logs. Secondary outcomes include examining the effect on mood, quality of life, function, and well-being, measured at 6 months post-psilocybin dosing.
Key inclusion criteria include having a DSM-5 diagnosis of Major Depressive Disorder, baseline MADRS score greater than or equal to 20, and stable psychotropic medication use. Exclusion criteria encompass significant cardiovascular conditions, epilepsy, substance use disorder within the past 12 months, and current or lifetime history of psychotic disorders or bipolar disorder.
The study, conducted at St. Vincent’s Hospital, Sydney, Australia, is led by Prof Jonathan Brett and funded by the Black Dog Institute. Recruitment is anticipated from November 2023 to December 2024, with the last data collection expected in October 2025.
Trial Details
This is a single centre, single arm study primarily examining the the safety, feasibility and acceptability of psilocybin-assisted psychotherapy in treatment resistant depression patients who are on concurrent psychotropic medication.NCT Number ACTRN12623000832673