The clinical study includes 35 participants with Major Depression Disorder. It will include subjects with an inadequate response to at least two FDA-approved antidepressant therapies, including the current course of antidepressant therapy, at a sufficient dose and duration for the current episode. An electroencephalography machine measures the brain’s activity at baseline and after four weekly low-dose IV ketamine study treatments. The purpose of the study is to learn about the neurological responses seen on EEGs of participants receiving low-dose IV ketamine therapy. Dr.
More than 264 million people across the globe suffer from depression. As a pervasive and often chronic health condition, depression is a global health burden and a significant source of disability. While depression might be considered a non-fatal health burden, severe depressive symptoms can lead to suicide, which is the second most common cause of death in people aged 15-29 years. Common treatments for depression include pharmacological interventions such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), and tricyclic antidepressants (TCAs) and psychotherapy; however, the efficacy of these interventions often fails in severe cases.
Ketamine is a dissociative anesthetic, used most frequently in veterinary medicine and pediatrics, that has been repurposed as an off-label analgesic and antidepressant. Extensive investigation of its rapid antidepressive effects have been a breakthrough offering a potential reprieve to those suffering from MDD. Ketamine has also been shown to reduce suicidal ideation in depressed patients at risk for suicide. Similarly, the administration of ketamine was effective at reducing depressive symptoms, acute suicidal behavior, and mood lability in the youth with treatment-resistant depression (TRD) and bipolar disease. Intranasal esketamine is the only form of ketamine that has been FDA-approved as a treatment for TRD. However, clinical research and real-world feasibility have established significant drawbacks to intranasal ketamine, including patient discomfort with administration, greater risk of diversion to the illicit market, and potentially serious adverse reactions. Intravenous use of racemic ketamine is the more established route of administration as it has long been used as an anesthetic at much higher doses.
"The upcoming clinical study for intravenous ketamine infusion in patients with treatment refractory major depressive disorder represents a significant milestone for
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