Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05624268
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2022-11-14
Brief Title:
Efficacy Safety and Tolerability of COMP360 in Participants With TRD
Sponsor:
COMPASS Pathways
Organization:
COMPASS Pathways
Study Overview
Official Title:
A Phase III Multicentre Randomised Double-blind Placebo-controlled Study to Investigate the Efficacy Safety and Tolerability of COMP360 in Participants With Treatment-resistant Depression
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Efficacy Safety and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression TRD
Detailed Description:
This is a phase III international multi-centre randomised parallel group fixed single-dose double-blind placebo-controlled study The study population will include participants aged 18 years with TRD
Overall 255 participants will be randomised in a 21 ratio to receive COMP360 25 mg or placebo
The study comprises three parts A B and C and will last approximately 62 weeks including a three- to ten-week Screening Period
Part A will include a six-week follow-up from initial investigational product IP administration
In this study the primary aim is to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD when administered with psychological support This will be assessed in a 6-week single-dose double-blind placebo-controlled part of the study Part A Durability of efficacy and long-term safety and the efficacy and safety of re-treatment will be assessed in a 20-week single-dose double-blind re-treatment part Part B and a 26-week open-label treatment part Part C
Overall 255 participants will be randomised in a 21 ratio to receive COMP360 25 mg or placebo
The study comprises three parts A B and C and will last approximately 62 weeks including a three- to ten-week Screening Period
Part A will include a six-week follow-up from initial investigational product IP administration
In this study the primary aim is to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD when administered with psychological support This will be assessed in a 6-week single-dose double-blind placebo-controlled part of the study Part A Durability of efficacy and long-term safety and the efficacy and safety of re-treatment will be assessed in a 20-week single-dose double-blind re-treatment part Part B and a 26-week open-label treatment part Part C
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