RecruitingPhase 2NCT05803551

A Study of Ketamine Infusions to Treat Clinically-depressed ICU Patients

A Phase II Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effects of Ketamine Infusions in Clinically Depressed ICU Patients


Sponsor

Mayo Clinic

Enrollment

50 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research is to study the effects of intravenous ketamine infusions for the treatment of patients with depressive symptoms in intensive care unit (ICU).


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether low-dose ketamine infusions can safely treat clinical depression in patients who are currently admitted to the ICU (intensive care unit) and are experiencing significant depressive symptoms on top of their critical illness. **You may be eligible if:** - You have been in the ICU at Mayo Clinic Florida for at least 1 week - You scored 10 or higher on a standard depression questionnaire (PHQ-9) - You have one of several serious medical diagnoses, such as heart attack, kidney failure, COPD, heart failure, liver disease, or are pre/post organ transplant **You may NOT be eligible if:** - Your vital signs are unstable (very low blood pressure, high blood pressure, low oxygen, abnormal heart rate or breathing) - You have confusion or altered mental status - You have a history of psychosis or hallucinations - You are allergic to ketamine or diphenhydramine (Benadryl) - You are pregnant or breastfeeding - You weigh more than 115 kg or less than 45 kg - You have increased pressure in the brain or eye 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 Hydrochloride

Intravenous 0.5 mg/kg infusions of ketamine for three consecutive days, 24 hours apart, with no more than 1mg/kg or 60 mg/day regardless of body weight

DRUGPlacebo

Intravenous 0.9% saline infusions for three consecutive days.


Locations(1)

Mayo Clinic Florida

Jacksonville, Florida, United States

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NCT05803551


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