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 or blood-related cancer that does not involve the brain.
• People whose cancer has been treated and who have shown no signs of the disease for the past 6 months.
• People aged 18 or older.
• People who have been formally diagnosed (using a structured clinical interview) with one or more of the following mental health conditions, which must have been triggered by the emotional stress of their cancer diagnosis: Generalised Anxiety Disorder; Acute Stress Disorder; Post-Traumatic Stress Disorder; Major Depressive Disorder; Dysthymic Disorder; or an Adjustment Disorder (with anxiety, depressed mood, mixed anxiety and depression, disturbance of conduct, or disturbance of both emotions and conduct). This diagnosis must be made by a qualified, licensed healthcare provider at MD Anderson.
• People who are reasonably well-functioning physically, as rated on a standard scale (ECOG score of 0, 1, or 2 — confirm with trial site for what this means for a specific situation).
• People with no major memory or thinking difficulties, who are aware of who they are, where they are, and what time it is.
• People who are willing and able to travel to MD Anderson Cancer Center for all treatment and follow-up visits, and to complete all study assessments.
• People who agree not to use any nicotine products for at least 8 hours before brain scan (fMRI) sessions.
• People who agree to avoid alcohol and other mind-altering substances for 48 hours before psilocybin sessions and for 12 hours afterward, and who consent to a urine drug test before receiving psilocybin. People who test positive may be retested after 6 weeks and may be eligible if the second test is negative. People who test positive only for a substance that has been prescribed to them may still be eligible.
• People who have stopped taking regularly scheduled antidepressant or anti-anxiety medications for at least 2 weeks before the study (some occasional, short-acting medications may be permitted — confirm with trial site).
• People who have stopped taking certain enzyme-inhibiting medications at least 5 half-lives before the active psilocybin dose (confirm with trial site which medications this applies to).
• People who can arrange a licensed driver to take them home after the psilocybin session; if a driver is used rather than a friend or family member driving, a friend or family member must also travel with them in the vehicle.
• People who are fluent in English.

Who may not be able to join:

• People who are considered at significant risk of suicide, including those who have had serious suicidal thoughts or any suicidal behaviour (such as an actual, interrupted, or aborted attempt, or preparatory actions) within the past year or two months, depending on the type of risk, or who the study doctor considers to be at serious risk.
• People with a history of bipolar disorder, psychosis, or schizophrenia.
• People with seriously limiting other conditions, such as a second cancer in the brain or chest, or a history of complete surgical removal of the voice box or tongue that prevents communication.
• People who are pregnant (a urine pregnancy test will be done at screening). Women who could become pregnant, and men whose partners could become pregnant, must agree to use an approved form of contraception for the full duration of the study. Women who are postmenopausal, or who have had certain surgeries that prevent pregnancy, may be exempt from this requirement (confirm with trial site).
• People who have a close blood relative (parent, sibling, or child) who has been diagnosed with schizophrenia, another psychotic disorder, or bipolar disorder I or II by a qualified mental health professional.
• People whose cancer is currently being treated with the aim of managing symptoms rather than curing the disease (palliative intent).
• Children and people with significant cognitive impairment.
• People who have cancer that has spread to the brain.
• People with very high blood pressure (above 180/120 mmHg) or a very high heart rate (above 110 beats per minute) at screening, baseline, or on the day of dosing. Note: the trial site will take multiple readings to account for normal variation.
• People with unstable or serious heart, kidney, liver, lung, or blood conditions that the study doctor considers unsafe for participation, including conditions such as heart failure, certain abnormal heart rhythms, recent heart attack, severe high blood pressure, a specific inherited heart condition (long QT syndrome), acute kidney failure, severe liver impairment, or breathing failure.
• People with significant brain or nervous system conditions, including brain tumours, epilepsy or any history of seizures (except a single fever-related seizure in childhood), a stroke in the past 3 years, an untreated brain aneurysm, dementia, or current delirium.
• People considered at high risk of a harmful emotional or behavioural reaction to psilocybin, based on the study team's assessment (such as a history of agitation or violent behaviour).
• People with a moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year.
• People who have used hallucinogens such as LSD or psilocybin in the past 12 months, or more than 22 times in their lifetime.
• People with a history of a condition called hallucinogen persisting perception disorder (HPPD), where visual disturbances continue after stopping hallucinogen use.
• People currently taking certain medications that cannot be stopped, including antidepressants, certain serotonin-affecting drugs, antipsychotics, mood stabilisers (such as lithium or valproic acid), certain enzyme-inhibiting drugs, serotonin-affecting dietary supplements (such as St. John's Wort or 5-HTP), or a medication called efavirenz.
• People who have a positive urine drug test for a range of substances, with some exceptions: people on a stable prescribed opioid dose for at least one month may continue; people on a stable prescribed benzodiazepine or non-benzodiazepine sleeping medication for at least six weeks may continue; people using cannabis (including legal cannabis) must agree to stop from the time of screening onward; people using prescribed stimulants (such as amphetamines or Ritalin) must agree to stop taking them at least 72 hours before the psilocybin dose and until 12 hours after.
• People with a psychiatric condition that the study team judges would make it difficult to build a safe and trusting relationship with the study therapists, or that makes psilocybin use unsafe.
• People who have any other physical or psychological symptom, medication use, or relevant finding that the study investigator considers would make participation unsuitable.
• People with a known allergy or intolerance to any ingredient in the study drug.
• People already enrolled in another clinical trial for anxiety, depression, or existential distress.
• Note: People with implants that are not compatible with MRI machines may still be eligible to participate but would not undergo the brain scanning component (confirm with trial site).

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