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NCT06480201 · ClinicalTrials.gov registry record · Phase 1
Gamma Oscillations as a Prognostic Marker for Ketamine Therapy in Treatment Resistant Depression
A Phase 1 study, sponsored by Texas A&M University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT06480201: Recruiting Phase 1 study, sponsored by Texas A&M University.
NCT06480201 is a Phase 1 study that is actively recruiting participants, run by Texas A&M University. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06480201, a Phase 1 study, is actively recruiting participants, sponsored by Texas A&M University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
The core objective of this study is to enhance the translational potential of this electroencephalogram (EEG) biomarker by using ketamine(KET)-induced gamma potentiation as a prognostic marker of 4-week treatment outcome. Previous research focused exclusively on KET-induced gamma band potentiation (GBP) in the context of a single infusion. Our study design captures the clinical variation associated with real-world treatment resistant depression (TRD) patients and allows us to analyze the relative importance of GBP to antidepressant symptom reduction across the induction phase of treatment. If successful, it provides a compelling rationale for a larger prospective investigation of gamma dynamics as a moderator of outcome to varied TRD therapies which impact the balance of cortical excitation and inhibition.
Primary Outcome
Gamma power is the resting state electroencephalogram represents the amplitude of oscillations measuring the in the 30+ hertz (Hz) range of the power-spectrum. This is used as a proxy measure of the level of cortical disinhibition occurring at rest.
Interventions
- DRUG Ketamine
- OTHER Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-01-01 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT06480201 shows while recruiting
NCT06480201 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.
NCT06480201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06480201 about?
NCT06480201 is a clinical study titled "Gamma Oscillations as a Prognostic Marker for Ketamine Therapy in Treatment Resistant Depression". The core objective of this study is to enhance the translational potential of this electroencephalogram (EEG) biomarker by using ketamine(KET)-induced gamma potentiation as a prognostic marker of 4-week treatment outcome. Previous research focused exclusively on KET-induced gamma band potentiation (...
What is the current status of trial NCT06480201?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2024-01-01. Estimated completion is 2026-12-31.
What interventions are being tested in trial NCT06480201?
The interventions under investigation include: Ketamine (DRUG), Saline (OTHER).
Who is sponsoring clinical trial NCT06480201?
This trial is sponsored by Texas A&M University, which has 95 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06480201's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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