Optimization of IV Ketamine for Treatment Resistant Depression
Existing treatments for major depressive disorder (MDD) generally take weeks to months to exert their maximal benefit. There is an urgent need to develop rapid-acting treatments for MDD. Ketamine, a high-affinity N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, has been used as a standard intravenous (IV) anesthetic agent for many years in both pediatric and adult patients. Beyond its well-established role in anesthesia and pain management, there is emerging evidence that ketamine may have rapid antidepressant properties for patients with severe mood disorders.
In this study we are investigating whether ketamine can have an antidepressant effect compared to midazolam. Midazolam has similar anesthetic effects compared to ketamine but has not been shown to be an antidepressant, and is therefore acting as an active control in this study.
The study period can last up to 8 weeks, depending on your response to the study medication. There are two required overnight stays in our Research Commons as part of this study.
|Major Depressive Disorder (MDD) Treatment Resistant Depression (TRD)||Drug: Ketamine Drug: Midazolam||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Optimization of Intravenous Ketamine for Treatment-Resistant Depression: A Randomized, Placebo-Controlled, Triple-masked, Clinical Trial|
- MADRS [ Time Frame: 24 hours post-infusion ]Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression.
|Study Start Date:||November 2008|
|Study Completion Date:||November 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Single dose .5 mg/kg IV (in the vein) infused over 40 minutes
Other Name: Racemic ketamine hydrochloride
Active Comparator: 2
single dose 0.045 mg/kg IV infused over 40 minutes
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768430
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|United States, Texas|
|Michael E. Dabakey VA Medical Center & Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sanjay J. Mathew, MD||Baylor College of Medicine|
|Principal Investigator:||Dan V Iosifescu, MD,M.Sc.||Icahn School of Medicine at Mount Sinai|