Ignite Creation Date:
2024-05-06 @ 1:43 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01880593
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2013-06-14
Brief Title:
Ketamine Plus Lithium in Treatment-Resistant Depression
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Ketamine Plus Lithium as a Novel Pharmacotherapeutic Strategy in Treatment-Resistant Depression
Status:
COMPLETED
Status Verified Date:
2018-07
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:
The purpose of this study is to test the antidepressant effect of ketamine when given repeatedly over a period of 1 week as well as the use of Lithium as a relapse-prevention strategy for patients with treatment-resistant depression TRD who respond to an initial series of ketamine infusions Ketamine is a Food and Drug Administration approved anesthetic a drug used to produce loss of consciousness before and during surgery Ketamine is not approved for the treatment of major depressive disorder and is considered experimental in this study An additional purpose of this study is to research the effects of ketamine on brain function
You may qualify to take part in this research study because you have been diagnosed with major depressive disorder MDD and have not responded to past treatments
You may qualify to take part in this research study because you have been diagnosed with major depressive disorder MDD and have not responded to past treatments
Detailed Description:
Major Depressive Disorder MDD is a disabling medical illness and current monoaminergic treatments are slow to act and possess only limited efficacy In this context the discovery that the glutamate NMDA receptor antagonist ketamine is rapidly antidepressant onset of action within hours -- even in patients suffering from treatment-resistant depression TRD -- has ignited tremendous enthusiasm among clinicians scientists and patients alike A critical obstacle to the translation of this discovery into a novel treatment however is the limited duration of action following a course of ketamine eg 1-2 weeks The current project will address this important gap in medical knowledge by testing a rational neuropharmacological strategy designed to optimize and sustain the rapid antidepressant effects of ketamine Driven by the recent characterization of the molecular mechanisms underpinning the antidepressant and neuroplasticity effects of ketamine we will test the combination of ketamine plus lithium in patients with TRD using a randomized double blind placebo-controlled design The primary aims of the project are 1 to test the efficacy of lithium-plus-ketamine compared to placebo-plus-ketamine as an antidepressant combination strategy in TRD and 2 to gather data on the safety and tolerability of the lithium-plus-ketamine
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