Ignite Creation Date:
2024-05-06 @ 9:03 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02882711
Status:
TERMINATED
Last Update Posted:
2020-11-24
First Post:
2016-08-22
Brief Title:
The UTHealth Ketamine Project
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
A Naturalistic Study of Serial Infusion of Low-dose Ketamine for Treatment Resistant Depressive Disorders in an Academic Psychiatric Hospital The UTHealth Ketamine Project
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Increasing off-label practice of IV ketamine administration for treatment-resistant depression
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to determine the effectiveness of serial infusions of intravenous IV ketamine in adults with treatment resistant depression TRD
Detailed Description:
Thus in the current study we want to naturalistically explore the antidepressant effects of serial slow IV infusions 40 minutes of ketamine at a dose of 05 mgkg over a treatment period of 8 weeks in an academic psychiatric hospital This is a minimal sedation treatment The primary outcome measure of this study will be remission estimated based on the severity of depressive scores After the 8 weeks of treatment there will be a four week observational period During the observational period participants will receive treatment as usual and will be contacted over the phone for follow-up questions regarding their overall health status mood and clinical state They will also complete a neurocognitive task at the end of the 4 week observational period
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