Evaluation of Schemes of Administration of Intravenous Ketamine in Depression

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Neurology and Neurosurgery, Mexico
• Treatments: Ketamine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Age: 18-65 years

2. MDD diagnosis as provided by DSM-5 criteria

3. TRD as defined by failure to achieve response to two consecutive antidepressant therapies at an adequate dose and duration

4. Patients approving inclusion by signing the informed consent

Exclusion Criteria:

1. Comorbidity with other mental and neurological disorders (except generalized anxiety disorder)

2. Substance use disorders at least 3 months prior to enrollment

3. Evidence of structural abnormalities in basal MRI

4. Pregnancy or lactation

5. Hypersensitivity to ketamine

6. Cardiac failure

7. Personal history of psychosis

8. First-degree relatives with history of psychosis

9. Uncontrolled close-angle glaucoma

10. Neurological disease (present)

11. Uncontrolled Hypertension

12. Contraindications for the realization of H1-MRS.