Phase 2 Parkinson's Disease 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 one of four specific conditions: COPD (confirmed by a specialist, with specific breathing test results, aged 40 or older, with at least 10 years of smoking history); ALS (diagnosed using the Gold Coast criteria, with specific functional scores); MS (diagnosed using the 2017 revised McDonald criteria, with a specific disability score); or Advanced Parkinson's Disease or a related condition such as Progressive Supranuclear Palsy or Multiple System Atrophy (diagnosed using recognised medical guidelines).
• People who meet the medical criteria for major depressive disorder, confirmed through a structured interview carried out by a psychologist or physician.
• People with a depression severity score (MADRS) above 19, indicating at least moderate depression.
• People with a life expectancy of at least 6 months, as assessed by a study doctor.
• People who are at least 18 years old.
• People who have an identified caregiver or support person available to them.
• People who are able to read and understand the consent forms and study questionnaires in their local language (for those with ALS, MS, or Parkinson's-related conditions, a neurologist will assess whether the person has the capacity to consent).
• People who are willing and able to attend all study visits, preparation sessions, follow-up sessions, and complete all required study tasks.
• People who are able to swallow capsules.

Who may not be able to join:

• People who have used a psychedelic substance (such as psilocybin, LSD, DMT, ayahuasca, or mescaline) in the past 6 months.
• People currently receiving treatment for another psychiatric condition that the screening clinician considers a more serious concern than their depression.
• People who meet the medical criteria for schizophrenia, other psychotic disorders, major depression with psychotic features, or bipolar I or II disorder.
• People who have ever been diagnosed at any point in their life with schizophrenia or another psychotic disorder.
• People who have a parent, sibling, or child with a diagnosis of schizophrenia, bipolar I disorder, or another psychotic disorder (unless caused by a substance or medication).
• People with a pre-existing psychiatric condition that the clinical team considers incompatible with safe participation in psilocybin therapy.
• People considered to have a significant risk of suicide, based on their responses to screening questions or clinical interview.
• People who currently meet the medical criteria for an active alcohol or drug use disorder.
• People currently taking antipsychotic medications (certain medications must have been stopped for a specific period before the study begins — confirm with trial site).
• People who are unwilling or unable to pause formal psychotherapy during the first 42 days of the study.
• People with neurological conditions such as brain tumours, epilepsy, or brain injuries that the study doctors expect would conflict with the treatment or study procedures.
• People with COPD who have had an unresolved flare-up or lung infection in the past 4 weeks.
• People with ALS or MS who have significant cognitive difficulties based on a specific cognitive test (MoCA).
• People with MS who also have epilepsy or a condition called radiologically isolated syndrome.
• People with Advanced Parkinson's Disease or related conditions who have dementia or a high level of daily functioning independence above a specific threshold on a recognised scale (confirm with trial site).
• People who have had a stroke or heart attack within the past year, have uncontrolled high blood pressure, a significant heart rhythm problem within the past year, or a specific abnormality in heart electrical activity on an ECG.
• People with moderate to severe liver disease, based on a specific medical scoring system.
• People with insulin-dependent diabetes, or who take diabetes tablets and are currently at risk of low blood sugar requiring medical treatment.
• People with any physical or psychological symptoms, medications, blood test results, or other findings that the clinical team considers would make participation unsafe.
• People with a known allergy or intolerance to any ingredient in the study medication.
• People who score significantly below the normal range on the Montreal Cognitive Assessment (MoCA), a standard cognitive test, after adjusting for age and education level.
• People who have had a change in antidepressant medication in the past two weeks, or who have a planned medication change during the study period.
• People who are pregnant, planning to become pregnant during the study, currently breastfeeding, or unwilling to use highly effective contraception during the study.

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