Phase 2 Depression and Anxiety Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a solid tumour that has spread to other parts of the body, or a blood cancer that cannot be cured, as confirmed by a doctor in their medical record
• Having measurable disease is not required to participate
• People who have previously received chemotherapy — there is no minimum or maximum number of prior chemotherapy treatments required
• People between 18 and 85 years of age
• People with a general physical functioning level rated 0 to 2 on the ECOG scale, meaning they are able to carry out at least some daily activities (confirm with trial site)
• People whose blood counts and organ function meet minimum levels: red blood cell levels (haematocrit) above 20, platelet count above 20,000, liver function test results no more than 1.5 times the upper limit of normal, and kidney function (creatinine) no more than 1.5 times the upper limit of normal
• People of childbearing potential who are willing to use effective contraception from the time of enrolment until at least one month after receiving the study treatment
• People who are at least four weeks past any surgery or radiotherapy at the time of joining the study — though people currently receiving oral or IV chemotherapy may still be considered if their treatment schedule can be adjusted around study sessions
• People who are motivated to take part in a group study and whom the research team judges to be able to participate effectively in small group sessions
• People who score 11 or higher on the Hospital Anxiety and Depression Scale (HADS) total score on pre-enrolment screening, indicating clinically significant anxiety or depressive symptoms
• People who are English-speaking and able to understand the consent process, including the risks and benefits of the study, and able to provide written informed consent
• People who are willing to sign a medical release allowing the investigators to communicate with their treating doctors, including their oncologist and any mental health professionals, to confirm medication and medical history
• People who can provide at least one adult who is in contact with them at least once a day while they are at home, who is able to monitor and report any changes in their behaviour to the research team
• People who are willing to have their use of antidepressants (such as SSRIs or SNRIs) reviewed as part of the study process
• People who are willing to avoid starting any new psychiatric medications during the study, and who agree to notify the study team if their doctor recommends doing so, which would require withdrawal from the study — noting that occasional use of benzodiazepines or gabapentoids as needed is allowed, though high-dose or ongoing use of either would need to be reviewed by the principal investigator
• People who can provide an emergency contact — such as a relative, spouse, close friend, or carer — who is reachable by the research team if the participant were to experience suicidal thoughts
• People of childbearing potential who have a negative pregnancy test at the start of the study and before the medication session, and who agree to use highly effective birth control (defined as methods with a failure rate of less than 1% per year, not including condoms or abstinence alone)
• People who are willing and able to attend all preparation sessions, medication dosing sessions, and integration sessions, complete all assessment questionnaires, and be available for all required phone contacts

Who may not be able to join:

• People who have brain metastases (cancer that has spread to the brain) that have not yet been treated
• People with uncontrolled or serious ongoing illness, including active infection, symptomatic heart failure, unstable chest pain, heart rhythm problems, or psychiatric or social circumstances that would make it difficult to follow the study requirements
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial or within 30 days after receiving the study treatment
• People who have a personal history, or an immediate family history, of schizophrenia, bipolar disorder, delusional disorder, paranoid disorder, or schizoaffective disorder
• People who are assessed as being at low risk or no risk of suicidal ideation based on the Columbia Suicide Severity Rating Scale (C-SSRS) (confirm with trial site)
• People with a current substance use disorder — though people with moderate alcohol use that does not meet the criteria for alcohol use disorder, or moderate cannabis use that does not meet the criteria for substance use disorder, would not automatically be excluded
• People with an unstable neurological or medical condition, or a history of seizures or chronic or severe headaches
• People who have used psychedelic substances at high doses — specifically more than 2 grams of dried psilocybin mushrooms or more than 200 micrograms of LSD — within the three months prior to joining; people who have been microdosing would not be excluded but would need to stop microdosing at least one month before starting the study
• People currently taking tramadol, due to the risk of a serious drug interaction (serotonin syndrome) when combined with psilocybin
• People currently taking monoamine oxidase inhibitors (MAOIs), or who have a known sensitivity to psilocybin or its breakdown products — psilocybin is also not compatible with certain medications that affect a group of enzymes called UGT enzymes (confirm with trial site)
• People with a prolonged QT or QTc interval on a standard heart tracing (ECG), specifically a QTc interval greater than 450 milliseconds
• People with additional risk factors for a serious heart rhythm problem called Torsade de Pointes, including heart failure, low potassium levels, or a family history of Long QT Syndrome
• People taking other medications that are known to prolong the QT or QTc interval
• People with any history of cardiovascular disease, including prior heart attack, congestive heart failure, or heart rhythm problems
• People taking the antiviral medication efavirenz who are unable to taper off it
• People taking serotonin-related supplements that may interact with psilocybin, including 5-HTP, St John's Wort, or supplements marketed as "brain food"

Important: Always verify eligibility with the trial site directly before applying.