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

This double-blind, randomized, low-dose comparator-controlled clinical trial (n=84) aims to assess the efficacy and safety of psilocybin (25mg; PEX010) in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to an incurable cancer diagnosis.

Participants aged between 18 and 80 years with anxiety following an incurable cancer diagnosis will be randomly allocated to one of three groups: a 25mg PEX010 dose group, a 10 mg PEX010 dose group, or a 1mg PEX010 dose group. The study consists of preparatory therapy sessions conducted by psychiatrists, psychologists, or psychotherapists, followed by a drug administration session where participants will receive a single administration of PEX010 under medical supervision. Integration sessions will then be conducted to process the drug-assisted experience.

The primary outcome measures include assessing changes in anxiety severity using the Hamilton Anxiety Rating Scale (HAM-A) and evaluating the safety and tolerability of PEX010. Secondary outcomes involve assessing changes in depression severity and adjustment disorder severity. Eligible non-responders at Week 12 may receive an additional treatment cycle. Long-term follow-up visits will assess safety and tolerability. The trial is not yet recruiting and is expected to commence enrolment by May 31, 2024, and conclude data collection by February 28, 2026.

Trial Details

This study is assessing the efficacy and safety of PEX010 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to incurable cancer diagnosis Who is it for? You may be eligible to join this study if you are aged between 18 and 80 years old, and you suffer from anxiety after adjusting to an acutely stressful event of your cancer diagnosis. We call that an adjustment disorder. Study details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg PEX010 dose group, a 10 mg PEX010 dose group or a 1mg PEX010 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with PEX010 administered at Day 14 (dosing day). At Week 12, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg PEX010). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3- and 6-months post Week 12 (of the final cycle) to assess safety and tolerability of PEX010. It is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.

NCT Number ACTRN12624000449538p

Data attribution

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