Ignite Creation Date:
2024-05-06 @ 3:09 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02219867
Status:
UNKNOWN
Last Update Posted:
2014-08-29
First Post:
2014-08-12
Brief Title:
Ketamine Infusions for Major Depression Disorder
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Evaluation of Safety and Efficacy of Sub-anesthetic Ketamine Infusions as a Treatment for Patients Diagnosed With Resistant Major Depression
Status:
UNKNOWN
Status Verified Date:
2014-08
Last Known Status:
NOT_YET_RECRUITING
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:
Ketamie
Brief Summary:
Ketamine has been safely used for induction and maintenance of anesthesia for decades and more recently has been used for chronic pain Ketamine is a noncompetitive high-affinity antagonist of the N-methyl-D-aspartate type glutamate receptor with additional effects on dopamine and μ-opioid receptors During the last 9 years several uncontrolled reports have been published showing a rapid and impressive effect of ketamine in TRD patients Berman Cappiello et al 2000 Zarate Singh et al 2006 Mathew Murrough et al 2010 Aan Het Rot Zarate et al 2012 Mathew Shah et al 2012 Murrough Iosifescu et al 2013 Recently three placebo-controlled trials showed that a single dose of sub-anesthetic 05 mgkg slow intravenous IV ketamine improves depressive symptoms dramatically Across studies a clinically significant antidepressant response was maintained for up to 72 hours in 12 of 25 patients Nonetheless all but two patients relapsed 2 weeks post-ketamine Zarate Singh et al 2006 aan Het Rot Zarate et al 2012 Rot et al showed that repeated IV ketamine infusions prolongs the duration of improvement
The investigators believe that the data presented above allows us to provide ketamine treatment here in the Sheba Medical Center for TRD patients
The investigators believe that the data presented above allows us to provide ketamine treatment here in the Sheba Medical Center for TRD patients
Detailed Description:
Major depressive disorder MDD is one of the leading causes of disability worldwide Collins Patel et al 2011 A substantial proportion of patients do not achieve adequate remission despite multiple antidepressant trials and augmentation strategies Rush Trivedi et al 2006 Weissman Pilowsky et al 2006 Treatment-resistant major depression TRD is defined as an insufficient response to at least two adequate antidepressant trials Rush Trivedi et al 2006 Many of these patients are referred to previous somatic treatment eg electroconvulsive therapy ECT rapid Transcranial Magnetic Stimulation rTMS and Vagal Nerve Stimulation VNS all of which have serious disadvantages andor limited efficacy
Ketamine has been safely used for induction and maintenance of anesthesia for decades and more recently has been used for chronic pain Ketamine is a noncompetitive high-affinity antagonist of the N-methyl-D-aspartate type glutamate receptor with additional effects on dopamine and μ-opioid receptors During the last 9 years several uncontrolled reports have been published showing a rapid and impressive effect of ketamine in TRD patients Berman Cappiello et al 2000 Zarate Singh et al 2006 Mathew Murrough et al 2010 Aan Het Rot Zarate et al 2012 Mathew Shah et al 2012 Murrough Iosifescu et al 2013 Recently three placebo-controlled trials showed that a single dose of sub-anesthetic 05 mgkg slow intravenous IV ketamine improves depressive symptoms dramatically Across studies a clinically significant antidepressant response was maintained for up to 72 hours in 12 of 25 patients Nonetheless all but two patients relapsed 2 weeks post-ketamine Zarate Singh et al 2006 aan Het Rot Zarate et al 2012 Rot et al showed that repeated IV ketamine infusions prolongs the duration of improvement
The investigators believe that the data presented above allows us to provide ketamine treatment here in the Sheba Medical Center for TRD patients
Ketamine has been safely used for induction and maintenance of anesthesia for decades and more recently has been used for chronic pain Ketamine is a noncompetitive high-affinity antagonist of the N-methyl-D-aspartate type glutamate receptor with additional effects on dopamine and μ-opioid receptors During the last 9 years several uncontrolled reports have been published showing a rapid and impressive effect of ketamine in TRD patients Berman Cappiello et al 2000 Zarate Singh et al 2006 Mathew Murrough et al 2010 Aan Het Rot Zarate et al 2012 Mathew Shah et al 2012 Murrough Iosifescu et al 2013 Recently three placebo-controlled trials showed that a single dose of sub-anesthetic 05 mgkg slow intravenous IV ketamine improves depressive symptoms dramatically Across studies a clinically significant antidepressant response was maintained for up to 72 hours in 12 of 25 patients Nonetheless all but two patients relapsed 2 weeks post-ketamine Zarate Singh et al 2006 aan Het Rot Zarate et al 2012 Rot et al showed that repeated IV ketamine infusions prolongs the duration of improvement
The investigators believe that the data presented above allows us to provide ketamine treatment here in the Sheba Medical Center for TRD patients
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