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CompletedNot applicable

(GluEsk) Glutamate and Esketamine

NCT06432322 · GluEsk · University of Oxford

Closed to entry
Status
Not accepting participants
Not applicable
Phase
16
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Esketamine is the S-enantiomer of racemic ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist. Esketamine and other antidepressant NMDA receptor antagonists are hypothesised to act by producing a rapid increase in brain glutamate release, which then stimulates α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptors. This activity in turn is thought to restore synaptic functioning, neuroplasticity, and connectivity in brain regions involved in mood regulation, which would be ultimately responsible for the antidepressant effect of esketamine. However, the effect of esketamine on glutamate release in humans has not previously been studied. In this study we therefore aim to ascertain the effect of esketamine on dynamic brain glutamate release, resting state connectivity, and neuroplasticity as measured via fMRS, BOLD-rs-fMRI, and a behavioural computerised visual task respectively.

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

  • Brain Glutamate Dynamic Change

    Measured over Acute (40-60 minutes after nasal spray application)

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 50 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Aged 18 to 50 years * Body Mass Index in the range of 18-30 * Sufficiently fluent in English to understand the study instructions * Willing and able to give informed consent for participation in the research Exclusion Criteria: * Currently on any regular prescribed medications (except the contraceptive pill), unless unlikely to compromise safety or affect data quality in the opinion of the Investigator * Known hypersensitivity to the study drug (i.e., esketamine) * History of, or current significant alcohol or substance misuse disorder * Any use of recreational drugs over the last 3 months * Any lifetime use of ketamine or phencyclidine (PCP) * Currently smoking \>/=20 cigarettes/day * History of, or current significant cardiovascular disorder (e.g., hypertension, myocardial infarction) * History of, or current significant neurological disorder (e.g., epilepsy, migraine) or cerebrovascular disorder (e.g., haemorrhagic or ischemic stroke, aneurysmal vascular disease, raised intracranial pressure) * History of, or current significant respiratory, hepatic, urinary tract, or thyroid disorders * History of, or current acute porphyria * History of, or current significant psychiatric disorder (e.g., psychosis, mania, depression) * History of, or current eye disorder, not including refractive error that can be corrected with glasses or contact lenses) * Pregnant, breast feeding, women of child-bearing potential not using appropriate contraceptive measures * Any contraindication to 7T MRI

Where

1 study site

FacilityCityRegionCountry
Department of Psychiatry, University of Oxford, Warneford HospitalOxfordOxfordshireUnited Kingdom

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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NCT06432322 on ClinicalTrials.gov →

Last updated in the registry 2025-06-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits