Subanesthetic Ketamine for Depressive Symptoms in ICU Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

KID-ICU is a Phase II, randomized, double-blind, placebo-controlled trial conducted at multiple centers. Adults in the ICU with moderate-to-severe depressive symptoms (PHQ-9 ≥ 10) after at least 6 days in the ICU will be assigned to receive ketamine 0.5 mg/kg (max 60 mg) or saline, given over 60 minutes once daily for two days. The PHQ-9 will track depressive symptoms, while safety and tolerability are monitored in the ICU setting. The study aims to determine whether subanesthetic ketamine can rapidly alleviate depressive symptoms in critically ill adults alongside standard critical care.

Why it matters

Who can join: the full rules

\*\*Inclusion Criteria:\*\*

* 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 Criteria:\*\*

* 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's running

• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• Hospital Italiano de Buenos Aires - Sede Central
  Buenos Aires, Buenos Aires, Argentina Recruiting

Study contacts

• Principal investigator: Ivan A Huespe, M.D., M.P.H. — Hospital Italiano de Buenos Aires
• Study coordinator: Ivan A. Huespe, M.D., M.P.H.
• Email: ivan.huespe@hospitalitaliano.org.ar
• Phone: +5493425382554

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.