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 are able to understand the study and agree to take part in it
• People who are comfortable speaking and writing in English
• People who have been diagnosed with idiopathic Parkinson's disease (the most common form of Parkinson's, not caused by another condition) by a neurologist, with disease at a mild-to-moderate stage when their Parkinson's medication or brain stimulation device is working
• People who are not expecting any changes to their Parkinson's medications or major surgery during the study period
• People who score 20 or above on a standard depression questionnaire (the BDI-2) at the start of the trial, indicating at least moderate depression symptoms
• People who can become pregnant and agree to use highly effective birth control from the time of joining through to four weeks after the second study session, and agree not to breastfeed during this time (accepted methods include an intrauterine device, hormonal contraceptives, condoms used together with another method, or complete abstinence from any sexual activity that could result in pregnancy)
• People who agree to stop taking any non-prescribed medications, nutritional supplements, or herbal supplements for one week before each study session, unless approved by the research team
• People who agree to stop all tobacco and nicotine use for the entire duration of the study
• People who agree to drink roughly the same amount of caffeinated drinks as usual on the mornings of study sessions
• People who agree to avoid sleep medications (such as benzodiazepines, zolpidem, zopiclone, or zaleplon) for an appropriate washout period before each study session and for 24 hours after
• People who agree to avoid opioid pain medications taken on an as-needed basis for an appropriate washout period before each study session and for 24 hours after
• People who agree to avoid products containing THC (the active ingredient in cannabis) and/or cannabidiol (CBD) for at least 7 days before each study session and for 24 hours after
• People who agree not to use non-prescribed narcotics (such as heroin or fentanyl), sedative drugs (such as barbiturates or benzodiazepines), or inhalants for the entire time they are in the trial
• People who agree not to drink alcohol for at least 24 hours before and 24 hours after each study session
• People who have a GP, neurologist, or psychiatrist who is actively involved in their care and available to be contacted by the study's medical team

Who may not be able to join:

• People whose movement symptoms are caused by a form of parkinsonism other than idiopathic Parkinson's disease
• People who show signs of significant memory or thinking difficulties, based on a standard cognitive test (a score below 24 on the MoCA)
• People who experience symptoms of low blood pressure when standing up (orthostatic hypotension)
• People currently receiving electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS); people who had these treatments must have finished at least 30 days before joining
• People who have taken part in another clinical trial or received an experimental treatment within the past 30 days (or longer, depending on the treatment)
• People who are pregnant, breastfeeding, or planning to become pregnant within 3 months of joining (a urine pregnancy test will be done during screening)
• People whose mental health symptoms are currently severe enough to require immediate treatment, as assessed by the study's medical team
• People considered at high risk of self-harm or suicide, based on a standard assessment — specifically, those who report intent to act on suicidal thoughts, or who have made a serious suicide attempt in the past 12 months
• People with a history of schizophrenia or other psychotic disorders, or a mood disorder with psychotic features, as defined by standard clinical criteria
• People with a history of delusions or other psychotic symptoms where they had no awareness that the symptoms were not real (exceptions may be considered by investigators if symptoms were caused by a substance or medication)
• People currently experiencing delusions or other psychotic symptoms where they have no awareness that the symptoms are not real
• People who have a parent, sibling, or child with a history of schizophrenia or a related psychotic disorder
• People who have a parent, sibling, or child with a history of bipolar disorder type 1 that began before age 40
• People with a current or past diagnosis of any form of bipolar disorder
• People with a current or recent history (within the last 2 years) of a moderate or severe alcohol or drug use disorder (not including caffeine)
• People with another current psychiatric condition that the investigators judge to be incompatible with safely taking part in the study
• People with a history of a condition called Hallucinogen Persisting Perception Disorder (HPPD), where visual disturbances continue after using a hallucinogenic substance
• People who have used psychedelic substances — including psilocybin, LSD, mescaline, DMT, ayahuasca, ibogaine, MDMA, or similar substances — in the past 6 months at levels the investigators consider clinically significant
• People with cancer that has spread to the brain or nervous system, an active brain or nervous system infection, or another major brain or nervous system condition besides Parkinson's disease
• People with epilepsy or a seizure disorder that started in adulthood
• People who require supplemental oxygen
• People with a known allergy or intolerance to any ingredients in the study drug
• People with significantly reduced kidney function (creatinine clearance below 40 ml/min)
• People with poorly managed hormonal conditions, such as uncontrolled diabetes or significant thyroid problems
• People with certain heart or blood vessel conditions, including: high blood pressure (systolic above 150 or diastolic above 95) at enrolment; a resting heart rate above 90 beats per minute at enrolment; a resting heart rate below 50 beats per minute at enrolment; angina (chest pain caused by reduced blood flow to the heart); a stroke within the past year; or a clinically significant abnormality on a heart tracing (ECG), including a QTc measurement above 450
• People with significant liver problems, indicated by certain blood test results being above acceptable levels (AST or ALT more than 3 times the upper limit of normal, or total bilirubin above 3.0 mg/dl)
• People currently taking certain medications that cannot be safely stopped before study sessions, including: medications that may cause serotonin syndrome (such as MAO inhibitors, St. John's Wort, SAM-e, 5-HTP, dextromethorphan, certain opioids, lithium, linezolid, or buspirone); medications that may affect how psilocybin works in the body (such as serotonin blockers, antipsychotics, certain anti-nausea medications, nicotine, certain antifungals, certain antivirals, valproate, or related drugs); medications that may increase the risk of psychotic symptoms (such as stimulants, certain anticholinergic medications, or systemic steroids); or tricyclic antidepressants
• People with any other medical condition, medication, test result, or health concern that the investigators determine would make participation unsafe or not feasible

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