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Recruiting NCT05803551

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

Phase II Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketamine Hydrochloride, Placebo.
Who it may be relevant to
Registry conditions: Depression. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug Ketamine 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
  • Drug Placebo
    Intravenous 0.9% saline infusions for three consecutive days.

Primary outcome measures

  • Change in depressive symptoms [Time frame: Baseline, 7 days after third infusion]
  • Clinically significant improvement of depressive symptoms [Time frame: 24 hours after initial infusion]
  • Clinically significant improvement of depressive symptoms [Time frame: 24 hours after third infusion]
  • Clinically significant improvement of depressive symptoms [Time frame: 14 days after third infusion]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic Florida — Jacksonville

Identifiers

NCT: NCT05803551 · 22-004767

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗