Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-01 @ 3:01 PM
Study NCT ID:
NCT04433858
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-09
First Post:
2020-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
Sponsor:
Sheppard Pratt Health System
Organization:
Study Overview
Official Title:
An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.
Detailed Description:
None
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?: