Psilocybin Therapy for Depression and Anxiety in Parkinson’s Disease (PDP)

The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy for depression and anxiety in people with Parkinson’s disease.

Topic Anxiety Depression Palliative Care
Compound Psilocybin
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 15 August 2021
End date 12 December 2022
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 10
Sex All
Age 40- 75
Therapy Yes

Trial Details

This is an open-label single-arm pilot study of oral psilocybin therapy for depression and anxiety in people with Parkinson's Disease (PD). The primary goal is to examine safety, tolerability, and feasibility of the intervention in this patient population. We will enroll ten people ages 40 to 75 with clinically diagnosed early stage Parkinson's Disease who meet DSM-5 criteria for a depressive or anxious disorder and meet all other inclusion and exclusion criteria at screening. After baseline assessments, participants will complete preparation sessions with trained facilitators followed by an initial drug administration session during which they will receive a low-moderate dose (10 mg) oral psilocybin in a supervised setting with safety monitoring by facilitators and a physician. Participants who do not experience significant adverse events during or following the session will complete a second drug administration session approximately two weeks later during which they will receive a moderate-high dose (25 mg) oral psilocybin. The second session will involve the same procedures and level of monitoring as the first. Participants will subsequently complete multiple follow-up sessions to assess PD motor symptoms, non-motor symptoms, and function. They will also complete integration sessions with facilitators to provide psychological support. Follow-up will continue to 3 months after the second psilocybin administration session. Primary endpoints will assess safety, tolerability and feasibility of study procedures. Exploratory efficacy endpoints will assess changes in depressive symptoms, anxious symptoms, and related measures of function/quality of life.

Trial Number NCT04932434

Sponsors & Collaborators

University of California San Francisco
At UCSF, there are two research teams dedicated to the study of psychedelics; the Neuroscape Psychedelic Division and the Translational Psychedelic Research Program.

Papers

Psilocybin therapy for mood dysfunction in Parkinson's disease: an open-label pilot trial
This open-label pilot study (n=12) found that psilocybin therapy (10mg followed by 25mg dose with psychotherapy) for Parkinson's disease patients with depression and/or anxiety appeared safe with no serious adverse events, whilst showing promising improvements in motor symptoms, cognitive function, depression and anxiety that persisted at three-month follow-up.

Data attribution

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