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NCT06788249 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study: Establishing Glutamatergic Changes in Rapid Antidepressant Effects of Ketamine
A Early Phase 1 study, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT06788249: Recruiting Early Phase 1 study, sponsored by University of Pennsylvania.
NCT06788249 is a Early Phase 1 study that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06788249, a Early Phase 1 study, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
relative change in glutamate concentration (% baseline)
Interventions
- DRUG Ketamine only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2026-08-15 |
| Phase | Early Phase 1 |
What NCT06788249 shows while recruiting
NCT06788249 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Ketamine only is the first listed.
NCT06788249 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06788249 about?
NCT06788249 is a clinical study titled "Pilot Study: Establishing Glutamatergic Changes in Rapid Antidepressant Effects of Ketamine". 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 ...
What is the current status of trial NCT06788249?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2026-04-01. Estimated completion is 2026-08-15.
What interventions are being tested in trial NCT06788249?
The interventions under investigation include: Ketamine only (DRUG).
Who is sponsoring clinical trial NCT06788249?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06788249's enrollment target sits among peer trials
10 1629th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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