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Ketamine only / Major Depressive Disorder (MDD) · Phase EARLY_PHASE1 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered early-phase pilot study investigating glutamatergic mechanisms of ketamine's antidepressant effect using novel GluCEST imaging in 10 patients with major depressive disorder. No results are yet posted; the study aims to generate mechanistic data that may inform future drug development, but findings from this small, uncontrolled cohort will not directly establish clinical efficacy or constitute practice-changing evidence.
Early Phase 1, Interventional, Single Group, Open label, Basic Science purpose. Major Depressive Disorder (MDD); age from 25 Years; to 65 Years. Intervention: Major Depressive Disorder. n = 10. 1 site: United States.
This is a registered early-phase pilot study investigating glutamatergic mechanisms of ketamine's antidepressant effect using novel GluCEST imaging in 10 patients with major depressive disorder. No results are yet posted; the study aims to generate mechanistic data that may inform future drug development, but findings from this small, uncontrolled cohort will not directly establish clinical efficacy or constitute practice-changing evidence.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This pilot study does not yet provide clinical guidance; results will be mechanistic only and require confirmation in larger, controlled trials before any implications for treatment can be drawn.
This is an early-phase pilot study (n=10) with a mechanistic focus using a novel imaging biomarker; no results are reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This pilot study does not yet provide clinical guidance; results will be mechanistic only and require confirmation in larger, controlled trials before any implications for treatment can be drawn.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06788249). This is a study registration, not published results. Lead sponsor: University of Pennsylvania. Recruitment status: RECRUITING. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 10 participants (ESTIMATED). Conditions: Major Depressive Disorder (MDD). Interventions: DRUG: Ketamine only. Primary outcome measures: GluCEST imaging metrics , From pre to post-ketamine infusion (2 imaging sessions over a 9-hour span). Brief summary: In the treatment of Major Depressive Disorder (MDD), ketamine can produce rapid but short-lasting improvements in mood. In order to develop a new generation of treatments with rapid and sustained efficacy, a better understanding of the mechanism of action is urgently needed. One candidate mechanism is the modulation of synaptic strength mediated by glutamatergic activity as ketamine has been suggested to increase synaptic strength. Although determining how ketamine impacts the glutamatergic system is essential to isolating its mechanism of action, the invasive nature of most assessment methods has limited our ability to do so in humans. The proposed research aims to determine if changes in glutamatergic activity, reflecting the modulation of synaptic strength, underlie the antidepressant effects of ketamine. In this project, the investigators will utilize a novel measure of glutamate imaging, GluCEST, to assess changes in glutamatergic activity to assess synaptic strength following ketamine administration. Ten individuals (aged 25-65) with a DSM-V diagnosis of MDD will undergo baseline GluCEST imaging prior to and following ketamine infusion. Both clinician-administered and subjective mood measures will be collected. It is predicted that ketamine will improve mood and increase glutamatergic activity and synaptic strength. Results from this project have the potential to identify the modifiable mechanisms by which rapid antidepressants work which could ultimately stimulate the development of novel interventions that work through the modulation of glutamatergic activity.
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