Ignite Creation Date:
2024-05-06 @ 12:29 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01582945
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2012-04-17
Brief Title:
Ketamine Infusion for Treatment-resistant Major Depressive Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
N-methyl-D-aspartate Antagonist Ketamine Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation
Status:
COMPLETED
Status Verified Date:
2017-04
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:
Ketamine infusion has been shown to have rapid antidepressant properties however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated The overall aim of this study is to assess the feasibility safety and tolerability efficacy and duration of the effect of intravenous N-methyl-D-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression TRD
This is an open-label study pilot
This is an open-label study pilot
Detailed Description:
Patients will undergo two weeks of prospective observation they will then receive ketamine IV 05mgkg over 45 minutes as augmentation of their ongoing antidepressant regimen after three infusions this dose will be increased increase to 075 mgkg in non-responders The schedule of administration will be twice a week for 3 weeks After this phase the patient will be followed with assessments every two weeks for three months
Total duration of the study is 5 months
Total duration of the study is 5 months
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