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TerminatedPhase 2

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

NCT05803551 · Mayo Clinic

Closed to entry
Status
Not accepting participants
Phase 2
Phase
1
Target enrolment
1
Study sites
1 US states

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in depressive symptoms

    Measured over Baseline, 7 days after third infusion

  • Clinically significant improvement of depressive symptoms

    Measured over 24 hours after initial infusion

  • Clinically significant improvement of depressive symptoms

    Measured over 24 hours after third infusion

  • Clinically significant improvement of depressive symptoms

    Measured over 14 days after third infusion

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 99 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * 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 Criteria: * 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.

Where

1 study site

FacilityCityRegionCountry
Mayo Clinic FloridaJacksonvilleFloridaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05803551 on ClinicalTrials.gov →

Last updated in the registry 2026-08-12. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits