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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06788249
The ClinicalTrials.gov registry entry for NCT06788249 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ketamine only is the first listed.
NCT06788249 reports 0 study locations.
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.
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