Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592833
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Psilocybin Mechanism of Action MOA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating the Role of Serotonin in the Mechanism of Action of Psilocybin in Patients With Major Depressive Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an interventional parallel arm assignment treatment study in individuals with Major Depressive Disorder MDD Each individual will be treated with a single dose of pimavanserin or placebo plus a single dose of psilocybin Evaluations will be taken before dosing and following dosing at several timepoints up to 5 weeks post-dosing
Detailed Description:
In this study the researchers want to probe the role of the 5-HT2A receptor in mediating the subjective effects of psilocybin While previous studies have shown that blockage of the 5-HT2A receptor reduces the psychedelic experience in humans an animal study revealed that blockage of the 5- HT2A receptor abolished the psychedelic effects without affecting the antidepressant response This suggests that the pathway responsible for the antidepressant response is dissociated from the psychedelic experience pathway which is mediated by 5-HT2A signaling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None