NCT05803551 · Mayo Clinic
A Study of Ketamine Infusions to Treat Clinically-depressed ICU Patients
What this study is about
The purpose of this research is to study the effects of given through a vein (IV) ketamine infusions for the treatment of patients with depressive symptoms in intensive care unit (ICU).
View original scientific description
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
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 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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Jacksonville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 8, 2025 · Source of record for eligibility and locations