RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-07-07

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05803551

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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. * History of increased intracranial pressure/hypertensive hydrocephalus or increased intraocular pressure. * Patient is acutely psychotic. * Provider feels that patient currently or likely will require chemical and/or physical restraints. * History of prolonged QT-interval. * Current treatment includes any medication known to affect the N-methyl-D-aspartate receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium). * Patient in withdrawal from substance abuse or who have used hallucinogens (including cannabis) in the last month for any indication, as determined by the clinical interview and urine drug screening.

Inclusion Criteria

Exclusion 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).

* 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.
* History of increased intracranial pressure/hypertensive hydrocephalus or increased intraocular pressure.
* Patient is acutely psychotic.
* Provider feels that patient currently or likely will require chemical and/or physical restraints.
* History of prolonged QT-interval.
* Current treatment includes any medication known to affect the N-methyl-D-aspartate receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium).
* Patient in withdrawal from substance abuse or who have used hallucinogens (including cannabis) in the last month for any indication, as determined by the clinical interview and urine drug screening.

Contacts and Locations

Principal Investigator

Devang Sanghavi, MBBS, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic Florida

Jacksonville, Florida, 32224

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Devang Sanghavi, MBBS, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-07

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-07-07

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Depression