An open-label study of the efficacy and feasibility of psilocybin-assisted psychotherapy for treatment-resistant depression (TRD)
Open-label, single-group Phase II study (n=15) of psilocybin-assisted psychotherapy for treatment-resistant depression: two 25 mg oral dosing sessions (6 weeks apart) with preparatory and integrative therapy over 12 weeks.
Details
This single-group, open-label study evaluates feasibility and efficacy of psilocybin-assisted psychotherapy in adults with treatment-resistant depression over a 12-week programme including two supervised 25 mg dosing sessions and nine non-drug therapy sessions.
Preparatory psychotherapy (3 sessions) precedes dosing; integrative psychotherapy (6 sessions total) follows dosing. Outcomes include change in depressive symptoms measured by QIDS self-rated and quality-of-life (WHO-QoL-Bref) at baseline, 3 weeks post-dose 1 and 2, and 20 weeks post-dose 2.
Dosing sessions occur at Swinburne University (Hawthorn campus) in a comfortable, living-room-like environment; vitals monitored and rescue benzodiazepines available for adverse psychological reactions.