Evaluation of Schemes of Administration of Intravenous Ketamine in Depression
Status:
Unknown status
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
Summary
Mexico, prevalence reported for major depressive disorder (MDD) is of 7.2%. It is currently
in the top 5 causes of disability worldwide. One third of patients will not achieve remission
after two treatments, being classified as treatment-resistant. In a neurochemical level,
evidence shows dysregulation of the excitatory neurotransmitter Glutamate in patients with
MDD. Chronic stress has been related to this dysregulation. Ketamine, has shown to regulate
glutamatergic neurotransmission, and specially promote the release and production of
neurotrophic factors key in the causes of MDD inhibited by glutamate dysregulation), and
allow restoration of areas affected.
Clinical studies of ketamine in MDD have shown robust, durable , and rapid effects (during
the first 4-24 hours), allowing a great opportunity for patients who do not achieve benefits
from antidepressants or patients with suicidal ideation . These results have been reported in
metaanalysis.
To our knowledge, there are no studies using Magnetic Resonance Spectroscopy, in areas
related to MDD, after a series of ketamine administrations, which we think may show changes
after this chronic administration and explain its antidepressant properties.
Goals: Provide clinical evidence of responseas well as a neurological basis or biomarker of
response to a series of ketamine infusions.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Neurology and Neurosurgery, Mexico