Unknown statusPhase 3

Evaluation of Schemes of Administration of Intravenous Ketamine in Depression

NCT03742557 · National Institute of Neurology and Neurosurgery, Mexico

Closed to entry

Status

Not accepting participants

Phase 3

Phase

Target enrolment

Study sites

Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Depression Severity Hamilton Depression Rating Scale
Measured over 4, 24, 72 hours, weekly up to 12 weeks or until relapse (Change from baseline to each measure)
Glutamate
Measured over Basal, 10 minutes during intervention, 24 hours after, 4 weeks after (Change from baseline to each measure)
GABA
Measured over Basal, 10 minutes during intervention, 24 hours after, 4 weeks after (Change from baseline to each measure)
Depression Severity Montgomery-Asberg Depression Rating Scale)
Measured over 4, 24, 72 hours, weekly up to 12 weeks or until relapse (Change from baseline to each measure). Higher values represent a worse severity, but not necessarily outcome.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years

Ages

All

Sex

Not accepted

Healthy volunteers

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.

Where

1 study site

Facility	City	Region	Country
Instituto Nacional de Neurología y Neurocirugía (National Institute of Neurology and Neurosurgery)	Mexico City	Tlalpan	Mexico

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT03742557 on ClinicalTrials.gov →

Last updated in the registry 2019-09-10. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication

Treatment Resistant Depression84

All 2 trials from National Institute of Neurology and Neurosurgery, Mexico →