Esketamine for Healthy Volunteers

1 paper and 4 clinical trials exploring esketamine as a treatment for healthy volunteers.

Compounddissociative

Esketamine

Esketamine (Spravato) is the S-enantiomer of ketamine, approved as an intranasal treatment for treatment-resistant depression and MDD with acute suicidal ideation. It is administered under clinical supervision with post-dose monitoring and has reached over $1.6 billion in annual sales.

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IndicationApproximately 300 million people affected by depression worldwide.

Healthy Volunteers

Research involving healthy volunteers has expanded to investigate the therapeutic potentials of various psychedelics for mental health conditions. Recent findings, emphasizing compounds like psilocybin and DMT, illustrate a promising future for psychedelic-assisted therapies.

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Academic Research

1 paper

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Acute effects of ketamine and esketamine on cognition in healthy subjects: A meta-analysis

This meta-analysis assessed the effects of ketamine administration in healthy participants (n=1,041) on several cognitive domains. Deficits in verbal learning/memory were most prominent, whereas response inhibition was the least affected. Negative effects were dependent on infusion dose and plasma level but unaffected by enantiomer type, route of administration, sex or age.

Published: August 1, 2022
Journal: Progress in Neuro-Psychopharmacology and Biological Psychiatry
Authors: Assaf, R., Li, C-S., Pelletier, R., Potvin, S., Tourjaman, V., Zhornitsky, S.

Clinical Trials

4 trials

Not yet recruitingPhase I

KF2024#1-trial: Esketamine Interaction Study

This open-label, Phase I trial (n=12) will investigate the effects of different methods of esketamine administration (28 mg nasal spray vs. 28 mg oral solution) with and without CYP3A4 inhibitors (grapefruit juice or cobicistat) on drug absorption and metabolism.

Started: December 9, 2024
Type: interventional
Blinding: none
Randomized: Yes
Registry ID: NCT06726382

CompletedPhase NA

(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.

Started: June 1, 2024
Type: interventional
Blinding: double
Randomized: Yes
Registry ID: NCT06432322

CompletedPhase I

A Phase I Randomized, Placebo Controlled, Double-Blind, Single-Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of PCN-101 (Arketamine) and a Relative Safety Comparison of PCN-101 and Esketamine in Healthy Volunteers

Phase I, randomized, double-blind, placebo-controlled study in healthy volunteers assessing single ascending IV doses of PCN-101 (arketamine) and a crossover relative safety comparison with esketamine (15 mg IV).

Started: February 25, 2020
Type: interventional
Blinding: double
Randomized: Yes
Registry ID: ACTRN12620000226909

RecruitingPhase I

Imaging Neural Correlates of Ketamine Using PET/MR

Randomized, placebo-controlled, double-blind crossover PET/MR study (n=65) comparing IV racemic ketamine and IV esketamine versus placebo in healthy adults to investigate pharmacodynamic differences using [18F]FDG PET/MR.

Started: January 10, 2020
Type: interventional
Blinding: double
Randomized: Yes
Registry ID: NCT04587778

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