This Phase I interventional trial (n=100) aims to evaluate ketamine (KET)-induced gamma potentiation as a prognostic marker for treatment outcomes in patients with treatment-resistant depression (TRD).
Conducted by Baylor College of Medicine and funded by the National Institute of Mental Health (NIMH), the study is set in Houston, Texas.
It will investigate the relationship between gamma band potentiation (GBP) measured by electroencephalogram (EEG) and the antidepressant efficacy of ketamine over a 4-week treatment period. Participants will receive either ketamine or saline infusions to determine how GBP correlates with symptom reduction in TRD.
The study seeks to enhance the understanding of gamma dynamics as a potential marker for predicting treatment response and guiding future research on neuromodulatory therapies for depression.
The trial began in January 2024 and is expected to conclude by December 2025.
Trial Details
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.NCT Number NCT06480201
Sponsors & Collaborators
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