Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05414422
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2022-05-27
Brief Title:
A Randomized Placebo-Controlled Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD
Sponsor:
Perception Neuroscience
Organization:
Perception Neuroscience
Study Overview
Official Title:
A Randomized Placebo-Controlled Double-Blind Study to Assess Safety and Efficacy of Intravenous PCN-101 in Treatment Resistant Depression
Status:
COMPLETED
Status Verified Date:
2022-12
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:
This is a double-blind randomized placebo-controlled multicenter study comprised of 3 phasesscreening up to 2 weeks Day -15 to Day -2 In-Clinic Treatment Day -1 to Day 2 including double-blind treatment Day 1 and post-treatment follow-up 7 and 14 days after infusion on Days 8 and 15 respectively A total of 93 adult subjects with TRD will be randomly allocated in equal cohorts of 31 subjectsarm to the 3 arms of the study in a blinded manner
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?:
None