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.

Topic Palliative Care Anxiety
Compound Psilocybin
Country Australia
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Trial Details



Trial Number

Sponsors & Collaborators

Psyence Group
Psyence is pioneering the use of natural psilocybin for the long-term treatment of trauma and its mental health consequences.

Data attribution

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