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NCT Number: NCT05803551

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

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).

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Devang Sanghavi

CONTACT

[email protected]

3146408772

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketamine Hydrochloride

Drug

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

Other names: Ketalar

Placebo

Drug

Intravenous 0.9% saline infusions for three consecutive days.

Primary outcomes

  1. Change in depressive symptoms

    Time frame: Baseline, 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.

  2. Clinically significant improvement of depressive symptoms

    Time frame: 24 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.

  3. Clinically significant improvement of depressive symptoms

    Time frame: 24 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.

  4. Clinically significant improvement of depressive symptoms

    Time frame: 14 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2023
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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