Optimization of IV Ketamine for Treatment Resistant Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00768430|
Recruitment Status : Completed
First Posted : October 8, 2008
Results First Posted : January 31, 2014
Last Update Posted : January 31, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder (MDD) Treatment Resistant Depression (TRD)||Drug: Ketamine Drug: Midazolam||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Optimization of Intravenous Ketamine for Treatment-Resistant Depression: A Randomized, Placebo-Controlled, Triple-masked, Clinical Trial|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||November 2012|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|