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Gamma Oscillations as a Prognostic Marker for Ketamine Therapy in Treatment Resistant Depression

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Lead sponsor: Texas A&M University to Texas A&M University Show 4 more changesShow less
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description revised
    • Site details revised at 1 of 2 sites
  2. Trial status: Suspended to Recruiting
    • Site details revised at 2 of 2 sites
    v5
  3. Trial status: Recruiting to Suspended Sponsor's reason: Paused while the study is transferred from Baylor College of Medicine to Texas A&M University.
    • Lead sponsor: Baylor College of Medicine to Texas A&M University
    • Site details revised at 2 of 2 sites
    v4
  4. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026
    • Study sites revised (2)
    v3
  5. Site contacts updated at 1 of 2 sitesv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Texas A&M University
34 trials monitored
See 5 trials at risk
Depression
3,055 trials monitored
See 173 trials at risk
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.
Trial Details
NCT Number NCT06480201
Lead Sponsor Texas A&M University
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 Healthy, Major Depressive Disorder, Treatment Resistant Depression
Related terms Depression, Depressive Disorder, Treatment-Resistant, Major Depressive Disorder
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov