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Pilot Study: Establishing Glutamatergic Changes in Rapid Antidepressant Effects of Ketamine

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later across 2 updates Aug 15, 2026 → Dec 15, 2026
See other at-risk trials from University of Pennsylvania

Record History

  1. Minor Primary and study completion pushed from Sep 15, 2026 to Dec 15, 2026 Eligibility criteria expanded, about 19 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 19 words
  2. Minor Site contact updatedv8
  3. Minor Primary and study completion pushed from Aug 15, 2026 to Sep 15, 2026v7
  4. Notable Recruitment opened Primary completion pushed from Mar 15, 2026 to Aug 15, 2026 · Completion pushed from Apr 15, 2026 to Aug 15, 2026 · Study sites: 0 to 1 · 1 morev6 Show 4 more changesShow less
    • Primary completion pushed from Mar 15, 2026 to Aug 15, 2026
    • Completion pushed from Apr 15, 2026 to Aug 15, 2026
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 1, 2026 to Apr 1, 2026
  5. Notable Start date: Dec 1, 2025 to Feb 1, 2026v5
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Start date: Oct 1, 2025 to Dec 1, 2025v4
  2. Notable Start date: Jul 15, 2025 to Oct 1, 2025v3
  3. Notable Start date: Mar 15, 2025 to Jul 15, 2025v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06788249
Lead Sponsor University of Pennsylvania
Conditions Major Depressive Disorder (MDD)
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov