Clinical TrialHealthy VolunteersEsketaminePlaceboCompleted

(GluEsk) Glutamate and Esketamine (GluEsk)

Randomised, double-blind, within-subject crossover study (n=16 actual) assessing single-dose intranasal esketamine 56 mg versus placebo on dynamic brain glutamate release, resting-state connectivity, and vision in healthy volunteers.

Target Enrollment
16 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

This within-subject crossover study uses a single 56 mg intranasal dose of esketamine versus placebo in healthy adults to test whether esketamine increases dynamic brain glutamate release measured by 7T fMRS, and to examine effects on resting-state BOLD connectivity and visual task performance.

Primary outcome is change in glutamate release during a flickering checkerboard stimulus measured by 7T fMRS. Secondary outcomes include resting-state connectivity (7T BOLD-rs-fMRI), behavioural visual task measures, and correlations with psychological questionnaires.

Study is conducted at the Department of Psychiatry, University of Oxford (Warneford Hospital); sponsor: University of Oxford. Design: randomized, double-blind, placebo-controlled crossover; participants complete two dosing sessions (esketamine and placebo).

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Esketamine

experimental

Single-dose esketamine nasal spray (56 mg total) in a within-subject crossover vs placebo.

Interventions

  • Esketamine56 mg
    via Other• single dose• 1 doses total

    Intranasal (28 mg per nostril)

Placebo

inactive

Intranasal placebo (0.9% NaCl) in crossover comparator arm.

Interventions

  • Placebo
    via Other• single dose• 1 doses total

    0.9% NaCl intranasal

Participants

Ages
18 – 50
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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 or breastfeeding, or women of child-bearing potential not using appropriate contraceptive measures
  • Any contraindication to 7T MRI

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment16 participants
  • Timeline
    Start: 2024-06-01
    End: 2025-06-30
  • Compounds
    EsketaminePlacebo
  • Topic
    Healthy Volunteers

Locations

Department of Psychiatry, University of Oxford, Warneford Hospital — Oxford, Oxfordshire, United Kingdom

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