RecruitingPhase 2NCT06668571

Intravenous Ketamine for Treatment-Resistant Depression

Central and Peripheral GABA and Glutamate Modulation With Intravenous Ketamine for Treatment-Resistant Depression (G2K): A Randomized, Double-Blind, Placebo-Controlled Study


Sponsor

Mayo Clinic

Enrollment

30 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to to evaluate the relationships between peak (% change from baseline) central GABA and Glu levels during a 40-min IV ketamine or normal saline infusion utilizing fMRS, and change in peripheral GABA and Glu levels from baseline to 24-hr postinfusion utilizing LCMS, with baseline to 24-hr post-infusion change in depression (MADRS) in 30 TRD adults.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests intravenous (IV) ketamine — a medication already used for anesthesia but now being explored as a fast-acting antidepressant — for people with treatment-resistant depression who have not responded to multiple standard antidepressants. **You may be eligible if...** - You have a diagnosis of major depressive disorder (without psychosis) - Your depression is severe (PHQ-9 score ≥ 15) - You have tried and failed at least two antidepressant treatments (medication, TMS, or ECT) in the current episode - You can understand English and pass a comprehension test about the study **You may NOT be eligible if...** - You have schizophrenia, bipolar disorder, active psychosis, or schizoaffective disorder - You have active PTSD symptoms - You have a BMI over 40 - You take high doses of benzodiazepines in the morning - You take certain medications that interact with ketamine (e.g., MAOIs, opioid blockers, certain seizure medications) within 2 weeks of treatment 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

The subjects will receive 1:1 single IV racemic ketamine (dosed @0.5 mg/kg actual body weight) (n=15) 40-min infusion in an MRI scanner, followed by an optional open-label ketamine infusion (available to everyone) 1-7 days after the initial treatment

DRUGNormal Saline

The subjects will receive 1:1 single IV normal saline/placebo (n=15) 40-min infusion in an MRI scanner, followed by an optional open-label ketamine infusion (available to everyone) 1-7 days after the initial treatment


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06668571


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