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RecruitingPhase 2

Subanesthetic Ketamine Infusions for Depressive Symptoms in Intensive Care Unit Patients

Ketamine In Depression - Intensive Care Unit Trial (KID-ICU): A Phase II Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Ketamine Infusion for Depressive Symptoms in Intensive Care Unit Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Eligible participants will be adult ICU patients with moderate-to-severe depressive symptoms, defined as a Patient Health Questionnaire-9 (PHQ-9) score of 10 or greater after 6 or more days of ICU admission."
  • "Participants assigned to the ketamine group will receive 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."
  • "Participants assigned to the placebo group will receive intravenous normal saline in an identical volume, appearance, and infusion duration."
  • "Study medication will be prepared by the research pharmacy in indistinguishable infusion bags."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether low-dose ketamine given through a vein can safely reduce depression symptoms in adults in an intensive care unit (ICU). It is for people who have been in the ICU for at least 6 days and have moderate to severe depression symptoms. Participants receive either ketamine or salt water with no active medicine once a day for 2 days.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 99 years.
  • Have been in the ICU for at least 6 days.
  • Have moderate to severe depression symptoms, with a score of at least 10 on the PHQ-9 depression survey.
  • Can understand the study and agree to take part.

Who can't join

  • Have or have had psychosis (trouble knowing what is real), hallucinations, dementia, or certain other mental health, thinking, or developmental disorders. This includes major depression before this ICU stay.
  • Have a history of a long QT interval (a heart rhythm problem), or currently have unsafe oxygen levels, blood pressure, heart rate, or breathing rate.
  • Have an allergy to ketamine or diphenhydramine.
  • Have a history of high pressure inside the skull or eyes, or fluid buildup that raises pressure in the brain. Also excluded: a mass or abnormal blood vessel inside the skull.
  • Are pregnant, gave birth within the past 2 months, or are breastfeeding; or weigh less than 45 kg or more than 115 kg.
  • Take lamotrigine, acamprosate, memantine, riluzole, lithium, or other medicines that affect the same brain system as ketamine; or take aminophylline or theophylline.
  • Are going through substance withdrawal, or used hallucinogens or cannabis in the past month.
  • Do not agree to take part, or have changes in thinking or awareness that prevent informed consent.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

\*\*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.

Study sites (1)

FL