Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455293
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-30
Brief Title:
Psilocybin Therapy for Depression in Parkinsons Disease
Sponsor:
Joshua Woolley MD PhD
Organization:
University of California San Francisco
Study Overview
Official Title:
The Efficacy of Psilocybin Therapy for Depression in Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PDP2
Brief Summary:
The purpose of this study is to understand whether people with Parkinsons Disease and depression have improvement in their symptoms after psilocybin therapy
Detailed Description:
This is a randomized controlled trial of oral psilocybin therapy for depression in people with Parkinsons disease PD The primary goal is to examine efficacy of psilocybin therapy in this patient population We will enroll 60 people ages 40 to 80 with clinically diagnosed early to moderate stage Parkinsons disease Hoehn and Yahr Stage 1-3 during an on period who meet criteria for moderate or greater depression severity and meet all other inclusion and exclusion criteria at screening Participants will complete two drug administration sessions where they will each receive a dose of oral psilocybin ranging from low microdose to high in a medically monitored setting with psychotherapeutic support Participants will also complete a series of psychotherapy sessions before and after each drug administration session Clinical assessments neuroimaging non-invasive brain stimulation and peripheral blood draws will be used to quantify changes in depression other non-motor and motor symptoms of PD quality of life and selected neural and blood-based biomarkers at multiple time points Follow-up will continue to 3 months after the second session Primary endpoints will evaluate efficacy safety and tolerability of study procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None