Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT04932434
Eligibility Criteria:
Inclusion Criteria:
* Age 40 to 75
* Comfortable speaking and writing in English
* Clinically diagnosed early stage Parkinson's Disease (Hoehn and Yahr Stage 1-3 during an "off" period) who meet DSM-5 criteria for a depressive or anxious disorder and meet all other inclusion and exclusion criteria at screening
* Currently experiencing depression and/or anxiety (a formal diagnosis is not necessary)
* Able to attend all in-person visits at UCSF as well as virtual visits
* Have a care partner/support person available throughout the study
* Have an established primary care provider, neurologist, or psychiatrist
Exclusion Criteria:
* Psychotic symptoms involving loss of insight
* Significant cognitive impairment
* Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate (NMDAR) antagonists, antipsychotics, and stimulants
* A health condition that makes this study unsafe or unfeasible, determined by study physicians
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT04932434
Study Brief:
Protocol Section:
NCT04932434