Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04519957
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2020-08-13
Brief Title:
Long Term Follow Up Study to COMP 001 And COMP 003 Trials P-TRD LTFU
Sponsor:
COMPASS Pathways
Organization:
COMPASS Pathways
Study Overview
Official Title:
Multicentre Study To Assess Safety And Efficacy Of Psilocybin In Patients With Treatment-Resistant Depression Following Completion Of COMP 001 And COMP 003 Trials P-TRD LTFU
Status:
COMPLETED
Status Verified Date:
2022-09
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 assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment hospitalisations for depression suicidality and depressive severity rated using the Montgomery and Asberg Depression Rating Scale MADRS over a total of 52 weeks compared across the 1 mg 10 mg and 25 mg psilocybin groups from COMP 001
Detailed Description:
In this present study COMP 004 the aim is to follow up participants from COMP 001 and COMP 003 in a long-term follow up study with both remote and digital assessments to explore the long term efficacy and safety of the three different doses of psilocybin 1 mg 10 mg and 25 mg administered to patients with TRD as a monotherapy in COMP 001 and 25 mg psilocybin administered as an adjunct to an SSRI in COMP 003 Patients previously treated in COMP001 will be followed for approximately 40 weeks and patients previosuly treated in COMP003 will be followed for approximately 49 weeks giving a total follow up period of 52 weeks from psilocybin dosing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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