Psilocybin Therapy for Depression in Parkinson's Disease
- Conditions
- Parkinson DiseaseDepression
- Registration Number
- NCT06455293
- Lead Sponsor
- Joshua Woolley, MD, PhD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria:<br><br> - Age 40 to 80<br><br> - Comfortable speaking and writing in English<br><br> - Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr<br> stages 1 to 3 during an on phase (time when medication/DBS for parkinsonian motor<br> feature, including bradykinesia and rigidity is in effect)<br><br> - Currently experiencing depressive symptoms<br><br> - Able to attend all in-person visits at UCSF as well as virtual visits<br><br> - Have a primary care provider, neurologist, or psychiatrist who is actively managing<br> or coordinating<br><br>Exclusion Criteria:<br><br> - Psychotic symptoms involving loss of insight<br><br> - Significant cognitive impairment<br><br> - Regular use of medications that may have problematic interactions with psilocybin,<br> including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate<br> tricyclic antidepressants, antipsychotics, and stimulants<br><br> - A health condition that makes this study unsafe or unfeasible, determined by study<br> physicians
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease
- Secondary Outcome Measures
Name Time Method Changes in depression severity;Changes in clinician-assessed depression;Changes in anxiety;Changes in PD symptom severity;Changes in Quality of Life;Changes in cognitive performance;Safety and tolerability of psilocybin therapy for depression in people with PD;Changes in clinician-rated psychotic symptoms;Subjective effects of psilocybin;Participant-reported acceptability of study procedures;Care partner/support person reported distress