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 Associated With Cancer.
This study is assessing the efficacy and safety of PEX010 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis. Who is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called 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 10, 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 months post Week 10 (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.
‣ To be eligible for study entry participants must satisfy all of the following criteria:
• Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score ≥ 47.5, a score of ≥ 4 on the Distress Thermometer.
• Screening HAM-A Score ≥18 (moderate anxiety).
• Adults aged 18 to 80 years (inclusive) at screening.
• Diagnosed with cancer (exempting those cancers listed in the exclusion criteria) and a minimum life-expectancy of 6 months in the opinion of the treating physician, with performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale performed at screening.
• Agrees not to commence any new psychiatric medications or psychotherapies from Screening to Week 10.
• Able to communicate well and follow study procedures, judged as sufficiently competent with the English language by the investigator, able to build adequate rapport with study staff.
• Judged to be of low suicide risk based on Sheehan-Suicide Tracking Scale (S-STS) and the opinion of a research team psychiatrist.
• Be medically suitable in the opinion of the investigator as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and blood tests.
• Have access to a device that is compatible to use the digital technology, i.e smart-phone device tablet.
⁃ Agree not to take any sedating medications for a minimum of 12 hours before the dosing session including benzodiazepines, zopiclone, eszopiclone, zaleplon and zolpidem. Medications for cancer-related pain are permitted.
⁃ Must be willing and able to refrain from smoking throughout the duration of the dosing session. Nicotine replacement therapies may be permitted with the agreement of the medical monitor.
⁃ Agree that for 1 week before the psilocybin dosing session, participants will refrain from taking any illegal drugs or non-prescription medication (including cannabis, or CBD or THC containing products), nutritional supplement, or herbal supplement except when approved by the study investigators. Additionally, agree not to take any form of psilocybin outside of the study, including microdosing, from baseline through Day 70/Week 10 (Visit 11).
⁃ Participants taking any other medication that is not explicitly detailed as an excluded medication will be discussed with the investigator and medical monitor as appropriate. Decisions on inclusion will be based on clinical judgement and with sufficient justification provided.