Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
This randomised, double-blind, low-dose comparator-controlled Phase IIb trial (n=87) will study the effects of different doses of psilocybin (PEX010; 1-10-25mg) delivered during a psilocybin-assisted psychotherapy (PAP) session in individuals with adjustment disorder following a cancer diagnosis.
Details
Randomised, double-blind Phase II study allocating 87 adults with adjustment disorder due to cancer 1:1:1 to 25 mg, 10 mg or 1 mg PEX010 during a supervised 8-hour psilocybin-assisted psychotherapy dosing session on Day 14.
Participants complete three preparatory sessions (two may be remote), an in-person dosing day, and integration contacts; non-responders at Week 10 may receive a second 25 mg PAP cycle (maximum two cycles), with final safety follow-up at 3 months after the final cycle.
Primary outcomes assess efficacy and safety for adjustment disorder symptoms (ADNM-20, HAM-A threshold eligibility) with monitoring of vitals, labs, and suicide risk throughout.