Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03149991
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2017-02-24
Brief Title:
A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression TRD
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression TRD
Status:
COMPLETED
Status Verified Date:
2020-07
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:
None
Brief Summary:
This is a multi-site double-blind placebo-controlled study of the acute efficacy of brexpiprazole or placebo in combination with intranasal ketamine added to ongoing stable and adequate antidepressant therapy ADT in the treatment of adults with Major Depressive Disorder with Treatment Resistant Depression
Detailed Description:
This is a five-site double-blind placebo-controlled study of the acute efficacy of oral brexpiprazole or placebo combined with intranasal ketamine added to ongoing stable and adequate antidepressant therapy ADT in the treatment of adults with MDD with TRD Adequate ADT is defined as a therapeutically sufficient dose for a sufficient treatment period which would be expected to be effective as listed in the MGH ATRQ
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