The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorYale University
About this trial
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
Eligibility criteria
Qualifiers
Able to understand and provide informed consent
Comfortable speaking and writing in English
Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an "on" phase (time when medication/DBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect)
Have no changes in medication or major surgical procedures anticipated for treatment duration
Disqualifiers
Any indication of forms of parkinsonism other than idiopathic Parkinson's disease.
Cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score <24.
Symptomatic orthostatic hypotension.
Currently receiving electroconvulsive therapy (ECT) or treatment via transcranial magnetic stimulation (TMS). Previous treatment with ECT and/or TMS is permitted; last treatment must be at least 30 days prior to entry into this trial.
Trial design
Treatments tested in this trial
- Psilocybin (drug)
- Psilocybin (drug)
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
Michael J. Fox Foundation for Parkinson's Research
Collaborator
Source ClinicalTrials.gov