Could a quick ketamine infusion lift depression in ICU patients?
NCT ID NCT07639359
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This study looks at whether a low dose of ketamine, given as an IV infusion, can quickly improve depressive symptoms in adults who have been in the intensive care unit (ICU) for at least 6 days. About 50 participants will receive either ketamine or a placebo on two days in a row. Researchers will check mood changes and safety over the next month.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
\*\*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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Italiano de Buenos Aires - Sede Central
RECRUITINGBuenos Aires, Buenos Aires, Argentina
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Mayo Clinic
RECRUITINGJacksonville, Florida, 32224, United States
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Other studies related to the condition(s) this trial covers.
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