At a glance
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Optimization of Intravenous Ketamine for Treatment-Resistant Depression: A Randomized, Placebo-Controlled, Triple-masked, Clinical Trial
In Brief
A Phase 2 clinical trial evaluating Ketamine and Midazolam for Major Depressive Disorder (MDD) and Treatment Resistant Depression (TRD). Completed, enrolled 73 participants across 2 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Single dose .5 mg/kg IV (in the vein) infused over 40 minutes
single dose 0.045 mg/kg IV infused over 40 minutes