Ketamine for Depression in ICU Patients
(KID-ICU Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether ketamine, a fast-acting antidepressant, can quickly relieve depression in ICU patients. Many ICU patients experience depression, which can slow recovery and affect overall health. Unlike regular antidepressants, ketamine acts quickly, but its safety and effectiveness in this setting remain unclear. Participants must have been in the ICU for at least six days and show moderate to severe signs of depression. The study compares ketamine to a placebo, a non-active treatment that looks the same, to determine its impact on mood and recovery. As a Phase 2 trial, this research measures ketamine's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.
Is there any evidence suggesting that ketamine is likely to be safe for ICU patients with depression?
Past studies have shown that ketamine is well-tolerated at low doses for treating depression. Administered through an IV at a controlled, low dose, it helps reduce serious side effects. Reported side effects include mild dizziness, nausea, or a temporary increase in blood pressure, which are typically short-lived and manageable.
Although ketamine is known for its quick antidepressant effects, its use in ICU patients for depression remains under study. Despite evidence supporting its safety in other contexts, ongoing evaluation is crucial for ICU patients. Researchers closely monitor study participants to ensure safety and manage any potential side effects.12345Why do researchers think this study treatment might be promising?
Researchers are excited about ketamine for treating depression in ICU patients because it offers a faster-acting alternative to traditional antidepressants like SSRIs or SNRIs, which often take weeks to show effects. Ketamine works differently by targeting the NMDA receptors in the brain, potentially providing rapid relief from depressive symptoms. Additionally, its administration as an intravenous infusion allows for precise control of dosage and immediate monitoring of patient response, which is crucial in a critical care setting.
What evidence suggests that ketamine might be an effective treatment for depression in ICU patients?
Research shows that ketamine can quickly alleviate depression symptoms. In some studies, patients felt better immediately after treatment, with benefits lasting up to a month. A review of various trials found that intravenous ketamine significantly reduced depression symptoms, even in those with major depressive episodes. One study found that more than half of the participants experienced significant relief from severe depression after just a few treatments. In this trial, participants in the experimental arm will receive intravenous subanesthetic ketamine. Early reports from ICU settings suggest ketamine might improve mood and sleep, but further research is needed to confirm these findings in seriously ill patients.678910
Who Is on the Research Team?
Devang K Sanghavi, M.B.B.S., M.D.
Principal Investigator
Mayo Clinic
Federico Carini, M.D.
Principal Investigator
Hospital Italiano de Buenos Aires
Ivan A Huespe, M.D., M.P.H.
Principal Investigator
Hospital Italiano de Buenos Aires
Are You a Good Fit for This Trial?
This trial is for adults (18-99 years old) who have been in the ICU for at least 6 days and are experiencing moderate to severe depression. Participants must be able to give informed consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous ketamine or placebo over 2 consecutive days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Ketamine
Trial Overview
The study compares two treatments: a low dose of intravenous ketamine versus a placebo (salt water), both given over two days, to see if ketamine quickly improves depressive symptoms in ICU patients. The trial is randomized and double-blind.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants receive intravenous subanesthetic ketamine at 0.5 mg/kg (maximum 60 mg/day regardless of body weight), administered over 40-60 minutes, once daily for 2 consecutive days. The drug is prepared by the research pharmacy in bags visually identical to placebo. Administration via peripheral or central venous access with continuous hemodynamic monitoring.
Participants receive intravenous normal saline (0.9% NaCl) prepared by the research pharmacy in bags visually identical to the ketamine preparation (same volume, color, and infusion duration of 40-60 minutes), once daily for 2 consecutive days. Identical hemodynamic monitoring and psychiatric assessment schedule as the experimental arm.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hospital Italiano de Buenos Aires
Lead Sponsor
Mayo Clinic
Collaborator
Citations
Efficacy of ketamine therapy in the treatment of depression
Ketamine has a robust and rapid effect on depression, which was seen immediately after the administration of ketamine and sustained at the end of 1 month.
Ketamine versus ECT for Nonpsychotic Treatment ...
The primary outcome was a response to treatment (i.e., a decrease of ≥50% from baseline in the score on the 16-item Quick Inventory of ...
Efficacy and Safety of Ketamine vs Electroconvulsive ...
This systematic review and meta-analysis of 6 trials with 340 patients suggests that ECT may be superior to ketamine in improving depression ...
IV Ketamine Shows Rapid Benefits for Suicide Risk ...
A meta-analysis of 26 trials found that IV ketamine rapidly reduced suicidal and depressive symptoms in patients with major depressive episodes.
International pooled patient-level meta-analysis of ...
Ketamine robustly reduces depressive symptoms in a heterogeneous range of patients, with benefit relative to placebo even greater in patients ...
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