Ketamine infusions to treat depression in ICU patients

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

This study will try IV ketamine infusions to see if they quickly reduce depression symptoms in ICU patients with a PHQ-9 score of 10 or higher.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 1 site (Jacksonville, Florida)
• Trial ID: NCT05803551 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study at Mayo Clinic Florida gives hospitalized ICU patients with significant depressive symptoms intravenous ketamine or placebo and monitors mood response. Eligible participants have been in the ICU for at least one week, have a PHQ-9 score of 10 or higher, and carry specified serious medical diagnoses such as myocardial infarction, respiratory failure, transplant-related care, or organ failure. Key exclusions include unstable vital signs, altered mental status, allergy to ketamine or diphenhydramine, or inability/unwillingness to provide consent. Mood outcomes and safety during and after the infusion period will be tracked to determine whether ketamine provides rapid symptom relief in this critically ill population.

Who should consider this trial

Good fit: Ideal candidates are patients admitted to the Mayo Clinic Florida ICU for at least one week with a PHQ-9 score of 10 or higher and one of the listed serious medical conditions (for example myocardial infarction, respiratory failure, transplant-related care, or organ failure).

Not a fit: Patients with unstable vital signs (for example oxygen saturation below 95% or extreme blood pressure, heart rate, or respiratory rate), altered mental status, allergy to ketamine or diphenhydramine, or who cannot or will not consent are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, ketamine could provide rapid relief from depressive symptoms for critically ill ICU patients who need faster-acting treatment than standard antidepressants.

How similar studies have performed: IV ketamine has demonstrated rapid antidepressant effects in outpatient and non-ICU inpatient populations, but its use specifically in medically critically ill ICU patients has been less extensively studied.

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.

Where this trial is running

Jacksonville, Florida

• Mayo Clinic Florida — Jacksonville, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Devang Sanghavi, MBBS, MD — Mayo Clinic

Conditions Depression