Clinical TrialDepressive DisordersKetaminePlaceboRecruiting

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

This double-blind, placebo-controlled Phase II trial (n=50) will investigate the effects of intravenous ketamine infusions on patients with depressive symptoms in the intensive care unit (ICU).

Target Enrollment
50 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, placebo-controlled Phase II study in ICU patients with depressive symptoms comparing IV ketamine 0.5 mg/kg once daily for three consecutive days versus saline placebo.

Primary aim is to evaluate efficacy and safety of repeated low-dose ketamine infusions for depressive symptoms in critically ill patients; assessments include PHQ-9 changes and safety/vital-sign monitoring.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

IV ketamine 0.5 mg/kg given once daily for three consecutive days to ICU patients with depressive symptoms.

Interventions

  • Ketamine0.5 mg/kg
    via IV• three consecutive days• 3 doses total

    0.5 mg/kg IV once daily; maximum permitted 1 mg/kg or 60 mg/day.

Placebo

placebo

IV 0.9% saline infusions for three consecutive days (placebo comparator).

Interventions

  • Placebo
    via IV• three consecutive days• 3 doses total

    0.9% saline

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion 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

  • Exclusion Criteria:
  • Poor vital sign stability: 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 45 kg.
  • 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.

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment50 participants
  • Timeline
    Start: 2023-12-01
    End: 2024-12-31
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

Mayo Clinic Florida — Jacksonville, Florida, United States

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