Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations.
Level 5 - mechanism / opinion, no new human data
Descriptive landscape review of trial registry entries without clinical outcome data synthesis
PubMed 39428602 · doi:10.1002/cpt.3478
What was done
A quantitative assessment of 363 clinical trials registered on ClinicalTrials.gov between 2014 and 2024 using the search term "Ketamine". The authors characterized trial patterns across FDA-approved indications, emerging psychiatric applications, development phases, and combinatorial regimens.
What was found
The largest shares of trials focused on established indications: pain management (~28%) and anesthesia (~22%) for ketamine, and treatment-resistant depression (TRD) for esketamine (~29%). TRD trials for both ketamine and esketamine progressed into phase III and phase IV. Trials increasingly investigated combinatorial strategies with pharmacological agents or non-pharmacological interventions (electroconvulsive therapy, psychotherapy, virtual reality, transcranial magnetic stimulation), as well as sub-anesthetic dosing for major depression, schizophrenia, and bipolar disorder.
Why it matters
This review outlines how clinical research for ketamine and esketamine has expanded beyond traditional anesthesia into advanced-phase psychiatric trials and multi-modal therapeutic strategies.
Limits
The analysis was restricted to ClinicalTrials.gov and a single search term, which may omit trials registered in other international databases. The abstract reports registry descriptive statistics only, with no evaluation of completed trial results, effect sizes, risk of bias, or clinical safety.
Cited by
- context Ketamine is an FDA-approved drug used to dissociate emotions in therapeutic contexts.