Ignite Creation Date:
2024-05-06 @ 4:17 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04932434
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2021-05-05
Brief Title:
Psilocybin Therapy for Depression and Anxiety in Parkinsons Disease
Sponsor:
Joshua Woolley MD PhD
Organization:
University of California San Francisco
Study Overview
Official Title:
Psilocybin Therapy for Depression and Anxiety in Parkinsons Disease a Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-06
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:
PDP1
Brief Summary:
The purpose of this study is to determine the safety tolerability and feasibility of psilocybin therapy for depression and anxiety in people with Parkinsons disease
Detailed Description:
This is an open-label single-arm pilot study of oral psilocybin therapy for depression and anxiety in people with Parkinsons Disease PD The primary goal is to examine safety tolerability and feasibility of the intervention in this patient population We will enroll people ages 40 to 75 with clinically diagnosed early stage Parkinsons 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 After baseline assessments participants will complete preparation sessions designed to provide information about the psilocybin experience and to build rapporttrust with the study team Next participants will complete a first psilocybin administration session receiving a low-moderate dose of 10 mg oral psilocybin in a supervised setting with safety monitoring by a physician Participants who do not experience significant adverse events during or following the session will complete a second psilocybin administration session approximately two weeks later During the second psilocybin administration session participants will receive a moderate-high dose of 25 mg oral The second session will involve the same procedures and level of monitoring as the first Participants will subsequently complete multiple follow-up sessions designed to assess PD and psychiatric symptoms as well as to provide support as they process their psilocybin experiences 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
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