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A Study of Ketamine Infusions to Treat Clinically-depressed ICU Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study of Ketamine Infusions to Treat Clinically-depressed ICU Patients

A Phase II Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effects of Ketamine Infusions in Clinically Depressed ICU Patients

NCT05803551•Mayo Clinic

View on ClinicalTrials.gov

Summary

The purpose of this research is to study the effects of intravenous ketamine infusions for the treatment of patients with depressive symptoms in intensive care unit (ICU).

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has been in the Mayo Clinic Florida ICU for the past 1 week.
•PHQ-9 score of 10 or higher.
•One of the following diagnoses: acute myocardial infarction; acute renal failure; chronic obstructive pulmonary disease (COPD); congestive heart failure; end-stage liver disease; patients requiring intra-aortic balloon pump (IABP) therapy or continuous renal replacement therapy (CRRT); post-bone marrow transplant; acute Hypoxemic Respiratory Failure; acute or chronic hypoxemic respiratory failure; pre- or post- lung, liver or heart transplant or surgical overflows (such as abdominal aortic aneurysm, thoracotomy or tracheostomy).

Exclusion Criteria

•Poor vital sign stability hypoxia: O2 \< 95%, hypotension: SBP \< 90 hypertension: SBP \> 180.
•Heart rate: \< 50 or \> 120, or Respiratory Rate: \< 10 or \> 30.
•Altered mental status.
•Patient is unwilling to participate or provide informed consent.
•Any allergy to ketamine or diphenhydramine.
•Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis.
•Pregnant or breastfeeding.
•Presence of intracranial mass or vascular lesion.
•Presence of a history of psychosis or hallucinations (as assessed by electronic chart review).
•Weight greater than 115 kg or less than 45kg.
+6 more criteria

Locations (1)

Mayo Clinic Florida

Jacksonville, Florida, United States

Key Dates

Start Date

July 7, 2025

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

August 8, 2025

Enrollment

ESTIMATED participants

Conditions

Depression

Interventions

Ketamine Hydrochloride

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Ketamine Infusions to Treat Clinically-depressed ICU Patients

Inclusion Criteria

Exclusion Criteria

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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