Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04608396
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2020-10-07
Brief Title:
Mechanistic Evaluation of Response in TRD MERIT
Sponsor:
Axsome Therapeutics Inc
Organization:
Axsome Therapeutics Inc
Study Overview
Official Title:
MERIT A Randomized Double-blind Placebo-controlled Study of AXS-05 for Relapse Prevention in Treatment Resistant Depression
Status:
COMPLETED
Status Verified Date:
2022-07
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:
MERIT
Brief Summary:
To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression TRD
This is a randomized double-blind placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after treatment with AXS-05
This is a randomized double-blind placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after treatment with AXS-05
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?:
True
Is an FDA AA801 Violation?:
None