Ignite Creation Date:
2024-05-06 @ 1:54 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01920555
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2013-08-08
Brief Title:
Double-Blind Placebo-Controlled Trial of Ketamine Therapy in Treatment-Resistant Depression TRD
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Double-Blind Placebo-Controlled Trial of Ketamine Therapy in Treatment-Resistant Depression TRD
Status:
COMPLETED
Status Verified Date:
2018-05
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 study is looking at the efficacy durability safety and tolerability of multiple single doses of Ketamine vs active placebo for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them
Detailed Description:
The primary objective is to investigate whether all doses 01 mgkg 02 mgkg 05 mgkg and 10 mgkg of ketamine are superior to active placebo midazolam 0045 mgkg therapy in the acute treatment of patients with treatment resistant depression within 72 hours Day 3 when added to ongoing and stable antidepressant therapy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 271201100006I-0-27100007-1 | NIH | None | httpsreporternihgovquickSearch271201100006I-0-27100007-1 |