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Evaluation of Schemes of Administration of Intravenous Ketamine in Depression

NCT03742557 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-09-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ketamine 50 MG/ML Injectable Solution, 0.5 mg/kg IV

Ketamine 0.5 mg/kg IV

Sponsors & Collaborators

  • National Institute of Neurology and Neurosurgery, Mexico

    lead OTHER

Principal Investigators

  • Rodrigo Pérez-Esparza, M.D., M.Sc. · National Institute of Neurology and Neurosurgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-01-01
Completion
2020-01-01

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03742557 on ClinicalTrials.gov