RecruitingPhase 1NCT06480201

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


Sponsor

Baylor College of Medicine

Enrollment

100 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study uses brain wave recordings (EEG) to examine whether a specific pattern of brain activity (gamma oscillations at 40 Hz) before or during ketamine treatment can predict who will respond to it — targeting patients with treatment-resistant depression (TRD), meaning their depression has not improved with standard antidepressants. **You may be eligible if...** - You are between 21 and 45 years old - You have a confirmed diagnosis of major depressive disorder that has not responded adequately to multiple antidepressant treatments - You are considered a candidate for ketamine therapy by your doctor - You are able to understand and consent to all study procedures **You may NOT be eligible if...** - You have bipolar disorder, active psychosis, or significant substance use disorder - You have medical conditions that make ketamine administration unsafe (e.g., uncontrolled blood pressure, certain heart conditions) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine

Ketamine infusion amount is dictated by BMI, sex, and age.

OTHERSaline

Saline infusion amount is dictated by BMI, sex, and age.


Locations(2)

Wells Medicine

Houston, Texas, United States

Texas A&M (Houston Methodist Hospital Location)

Houston, Texas, United States

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NCT06480201


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