50 Participants NeededMy employer runs this trial

Ketamine for Depression in ICU Patients

(KID-ICU Trial)

Recruiting at 1 trial location
II
IA
Overseen ByIvan A. Huespe, M.D., M.P.H.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Hospital Italiano de Buenos Aires
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

DK

Devang K Sanghavi, M.B.B.S., M.D.

Principal Investigator

Mayo Clinic

FC

Federico Carini, M.D.

Principal Investigator

Hospital Italiano de Buenos Aires

IA

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

I am between 18 and 99 years old.
I am male or female.
I have been in the ICU for 6 or more days at screening.
See 2 more

Exclusion Criteria

I am currently taking aminophylline or theophylline.
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
I do not agree to participate or give my consent for the study.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous ketamine or placebo over 2 consecutive days

2 days
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days
4 visits (in-person or telephone)

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

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

Group I: KetamineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hospital Italiano de Buenos Aires

Lead Sponsor

Trials
126
Recruited
14,150,000+

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+

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 ...

6.

pcori.org

pcori.org/

PCORI | Patient-Centered Outcomes Research Institute

PCORI funds comparative clinical effectiveness research (CER) that helps people make informed healthcare decisions and improves healthcare delivery and outcomes ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29655837/

Outcomes of Early Liver Transplantation for Patients ... - PubMed

We collected data on baseline characteristics, psychosocial profiles, level of alcohol consumption before LT, disease course and treatment, and outcomes of LT.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34331914/

Downstaging Outcomes for Hepatocellular Carcinoma - PubMed

Probability of successful downstaging to Milan criteria and dropout at 2 years from the initial downstaging procedure was 87.7% and 37.3%, respectively.

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27797935/

High hospital research participation and improved ...

Patients treated in Trusts with high research participation (≥16%) in their year of diagnosis had lower postoperative mortality (p<0.001) and improved survival

Impact of Doulas on Healthy Birth Outcomes - PMC

The data sample provided the opportunity to conduct a comparison of the impact of doula versus nondoula assistance on birth outcomes. The race/ethnicity and ...