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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 15, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT06480201). This is a study registration, not published results. Lead sponsor: Texas A&M University. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Healthy, Major Depressive Disorder, Treatment Resistant Depression. Interventions: DRUG: Ketamine; OTHER: Saline. Primary outcome measures: Resting State Gamma Power , Before infusion, during infusion, 60-90 minutes after infusion; Auditory Steady State Response Gamma Power , Before infusion, during infusion, 60-90 minutes after infusion; Montgomery-Asberg Depression Rating Scale (MADRS) , Study entry, pre-infusion, study exit visit (up to a month after infusion). Brief 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.