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NCT07639359

Subanesthetic Ketamine Infusions for Depressive Symptoms in Intensive Care Unit Patients

Recruiting
PHASE2Ages 18–99InterventionalTreatment
Hospital Italiano de Buenos Aires
~50 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Ketamine (0.5 mg/kg)Normal Saline (0.9% NaCl)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in PHQ-9 Score from Baseline to Day 30 Post-Last Infusion
Measured over From baseline (before first infusion, Day 0) to Day 30 after the last infusion
+1 more outcome measured

Conditions

Depression Disorder
Ketamine

Explore related trials

Depressive disorderN-Methyl-D-Aspartate Receptor

Where it's being run

2 sites across 2 states
Florida1
Buenos Aires1

Study leadership

  • Ivan A Huespe, MD · PRINCIPAL_INVESTIGATOR · Hospital Italiano de Buenos Aires
  • Devang K Sanghavi, M.B.B.S., M.D. · STUDY_DIRECTOR · Mayo Clinic
  • Federico Carini, M.D. · STUDY_CHAIR · Hospital Italiano de Buenos Aires

Who to contact

Ivan IH Huespe, MD
[email protected]
+5493425382554
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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Change in PHQ-9 Score from Baseline to Day 30 Post-Last InfusionFrom baseline (before first infusion, Day 0) to Day 30 after the last infusion

    The Patient Health Questionnaire-9 (PHQ-9) is a validated 9-item self-report scale measuring the severity of depressive symptoms (score range 0-27; higher scores indicate greater severity). The primary efficacy endpoint is the change in PHQ-9 total score (ΔPHQ-9 = baseline score minus Day-30 score), where positive values indicate improvement.

  • Incidence of Safety Events During and After Ketamine InfusionDuring infusion and up to 240 minutes after each infusion (Days 1 and 2), and at follow-up visits (Days 1, 7, 14, and 30 post-last infusion)

    Safety is assessed by the incidence of: (1) clinically significant hemodynamic instability requiring intervention (severe hypertension SBP ≥180 mmHg or DBP ≥110 mmHg requiring antihypertensives; sustained tachycardia ≥160 bpm; bradycardia \<50 bpm; vasopressor initiation); (2) acute neuropsychiatric events (confusion, agitation, disorientation, dissociation, hallucinations, psychotic symptoms); (3) treatment discontinuation due to adverse events. Assessed using the Ketamine Side Effect Tool (KSET) and continuous monitoring.