A Phase 2b double-blind, randomized, low-dose comparator-controlled clinical trial to assess the efficacy and safety of PEX010 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to incurable cancer diagnosis
Double-blind, randomized 1:1:1 Phase 2b dose-comparison trial (n=84) comparing single oral 25 mg, 10 mg and 1 mg PEX010 plus psychotherapy for adjustment disorder due to an incurable cancer diagnosis.
Details
This interventional, double-blind randomized trial compares three doses of oral PEX010 (25 mg, 10 mg, 1 mg) administered as a single supervised dosing session (Day 14) paired with preparatory and integration psychotherapy in participants with adjustment disorder following an incurable cancer diagnosis.
Participants complete three preparatory therapy sessions in the two weeks prior to dosing (two may be remote), an ~8-hour supervised drug session with therapist support and mouth checks, and integration sessions on Day 15 and Day 21, with follow-up visits through Day 253; non-responders at Week 12 may be offered a second PAP cycle (max 2).
Primary outcome is change in anxiety severity measured by HAM-A; key secondary and safety assessments include ADNM-20, S-STS, vitals, ECG and laboratory monitoring.