Subanesthetic Ketamine Infusions for Depressive Symptoms in Intensive Care Unit Patients
Recruiting · NCT07639359 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Italiano de Buenos Aires
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Depressive symptoms are common among patients admitted to the intensive care unit (ICU) and may adversely affect recovery, participation in care, treatment adherence, quality of life, and outcomes after critical illness. Conventional antidepressants have limited utility for rapidly treating depressive symptoms during an ICU admission because of their delayed onset of action and potential drug interactions in medically complex patients. Ketamine is an N-methyl-D-aspartate receptor antagonist with rapid antidepressant effects when administered intravenously at subanesthetic doses. However, evidence regarding its efficacy and safety for depressive symptoms developing during critical illness remains limited. The KID-ICU trial is a Phase II randomized, double-blind, placebo-controlled, multicenter trial evaluating subanesthetic intravenous ketamine for moderate-to-severe depressive symptoms in adult ICU patients. Eligible participants are adults who have been admitted to an ICU for 6 or more days and have a Patient Health Questionnaire-9 (PHQ-9) score of 10 or greater. Participants will be randomized in a 1:1 ratio to receive either intravenous ketamine at 0.5 mg/kg, with a maximum dose of 60 mg per infusion, administered over 60 minutes once daily for 2 consecutive days, or normal saline placebo with an identical volume, appearance, and infusion duration. The primary efficacy outcome is the change in PHQ-9 total score from baseline to Day 14 after the second scheduled infusion. Secondary outcomes include the longitudinal trajectory of PHQ-9 scores through Day 30, clinically meaningful PHQ-9 response at Day 14, anxiety and depressive symptoms assessed with the Hospital Anxiety and Depression Scale, Clinical Global Impression scores, prespecified safety events, time to ICU and hospital discharge alive, and 30-day all-cause mortality. A total of 50 participants will be enrolled across participating ICUs in Argentina. Psychiatric and clinical follow-up will be provided to all participants regardless of treatment assignment.
Who can take part
Inclusion criteria
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- Age 18 to 99 years.
- Male or female.
- Admission to an intensive care unit for 6 or more days at the time of screening.
- Moderate to severe depressive symptoms, defined as a Patient Health Questionnaire-9 score of 10 or greater at screening.
- Ability to provide informed consent.
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Exclusion criteria
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- History of psychosis or hallucinations, as assessed by review of the electronic medical record and patient interview during screening.
- History of prolonged QT interval.
- History of dementia.
- History of major depressive disorder before the current intensive care unit admission.
- History of psychiatric diagnosis, including dissociative disorder, primary psychotic disorder, mania with psychosis, pervasive developmental disorder, cognitive disorder, or anorexia nervosa.
- Known allergy to ketamine or diphenhydramine.
- History of increased intracranial pressure, hypertensive hydrocephalus, or increased intraocular pressure.
- Hemodynamic instability at the time of screening, defined as peripheral oxygen saturation \<95%, systolic blood pressure \<90 mmHg or \>180 mmHg, heart rate \<50 or \>120 beats/min, or respiratory rate \<10 or \>30 breaths/min.
- Patient refusal to participate or to provide informed consent.
- Pregnancy, postpartum period within 2 months, or breastfeeding.
- Presence of intracranial mass or vascular lesion.
- Altered mental status precluding informed consent.
- Body weight \>115 kg or \<45 kg.
- Active psychosis.
- Current treatment with medications that may interfere with the N-methyl-D-aspartate receptor system, including lamotrigine, acamprosate, memantine, riluzole, or lithium.
- Current treatment with aminophylline or theophylline.
- Active substance withdrawal or use of hallucinogens, including cannabis, in the past month, as determined by clinical interview and urine drug screening.
Where it is running
2 locations listed across 1 US state.
- Mayo Clinic - Jacksonville, Florida, United States
- Hospital Italiano de Buenos Aires - Sede Central - Buenos Aires, Buenos Aires, Argentina