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Ketamine Infusions for Depression in ICU Patients

This study is looking at whether intravenous (IV) infusions of ketamine hydrochloride can help treat depression in patients who are in the intensive care unit (ICU). You might be able to join if you are in the Mayo Clinic Florida ICU, are between 18 and 99 years old, and have a PHQ-9 score (a measure of depression symptoms) of 10 or higher. You also need to have one of several specific medical conditions, such as a heart attack or congestive heart failure. Researchers will compare ketamine to a placebo (a salt water solution) to see if ketamine can reduce depressive symptoms within 24 hours and up to 7 days after the infusions. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 50 participants. It compares ketamine hydrochloride infusions to a placebo.
What's involved
Participants will receive intravenous infusions for three consecutive days, 24 hours apart. The study measures changes in depressive symptoms at baseline, 24 hours after the first and third infusions, and 7 days after the third infusion.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 7 days after the third infusion to assess changes in depressive symptoms.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05803551

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

Terminated
PHASE2Ages 18–99InterventionalTreatment
Mayo Clinic
~1 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Ketamine HydrochloridePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in depressive symptoms
Measured over Baseline, 7 days after third infusion
+3 more outcomes measured

Conditions

Depression

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Depression

NCT05803551

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic Florida

    Jacksonville, Floridano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Devang Sanghavi, MBBS, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Has been in the Mayo Clinic Florida ICU for the past 1 week.
PHQ-9 score of 10 or higher.
One of the following diagnoses: acute myocardial infarction; acute renal failure; chronic obstructive pulmonary disease (COPD); congestive heart failure; end-stage liver disease; patients requiring intra-aortic balloon pump (IABP) therapy or continuous renal replacement therapy (CRRT); post-bone marrow transplant; acute Hypoxemic Respiratory Failure; acute or chronic hypoxemic respiratory failure; pre- or post- lung, liver or heart transplant or surgical overflows (such as abdominal aortic aneurysm, thoracotomy or tracheostomy).

Exclusion

Poor vital sign stability hypoxia: O2 \< 95%, hypotension: SBP \< 90 hypertension: SBP \> 180.
Heart rate: \< 50 or \> 120, or Respiratory Rate: \< 10 or \> 30.
Altered mental status.
Patient is unwilling to participate or provide informed consent.
Any allergy to ketamine or diphenhydramine.
Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis.
Pregnant or breastfeeding.
Presence of intracranial mass or vascular lesion.
Presence of a history of psychosis or hallucinations (as assessed by electronic chart review).
Weight greater than 115 kg or less than 45kg.
History of increased intracranial pressure/hypertensive hydrocephalus or increased intraocular pressure.
Patient is acutely psychotic.
Provider feels that patient currently or likely will require chemical and/or physical restraints.
History of prolonged QT-interval.
Current treatment includes any medication known to affect the N-methyl-D-aspartate receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium).
Patient in withdrawal from substance abuse or who have used hallucinogens (including cannabis) in the last month for any indication, as determined by the clinical interview and urine drug screening.

What this trial measures

  • Change in depressive symptomsBaseline, 7 days after third infusion

    Evaluated by Patient Health Questionnaire-9 (PHQ-9) used to assess degree of depression severity rating symptoms on a scale of 0=not at all, 3=nearly everyday. Higher score indicates greater depression severity.

  • Clinically significant improvement of depressive symptoms24 hours after initial infusion

    Number of subjects to show clinically significant improvement in depressive symptoms, defined as a reduction in the PHQ-9 of 5 points or more.

  • Clinically significant improvement of depressive symptoms24 hours after third infusion

    Number of subjects to show clinically significant improvement in depressive symptoms, defined as a reduction in the PHQ-9 of 5 points or more.

  • Clinically significant improvement of depressive symptoms14 days after third infusion

    Number of subjects to show clinically significant improvement in depressive symptoms, defined as a reduction in the PHQ-9 of 5 points or more.