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

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05803551

Collaborator

(none)

Enrollment

Location

Arms

19.1

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Ketamine Hydrochloride Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketamine Group Adult patients who have been in the Mayo Clinic Florida ICU for one week with moderate or severe depression will receive intravenous (IV) ketamine	Drug: Ketamine Hydrochloride Intravenous 0.5 mg/kg infusions of ketamine for three consecutive days, 24 hours apart, with no more than 1mg/kg or 60 mg/day regardless of body weight Other Names: Ketalar
Placebo Comparator: Placebo Group Adult patients who have been in the Mayo Clinic Florida ICU for one week with moderate or severe depression will receive intravenous (IV) placebo	Drug: Placebo Intravenous 0.9% saline infusions for three consecutive days.

Arm

Intervention/Treatment

Experimental: Ketamine Group

Adult patients who have been in the Mayo Clinic Florida ICU for one week with moderate or severe depression will receive intravenous (IV) ketamine

Drug: Ketamine Hydrochloride

Intravenous 0.5 mg/kg infusions of ketamine for three consecutive days, 24 hours apart, with no more than 1mg/kg or 60 mg/day regardless of body weight

Other Names:

Ketalar

Placebo Comparator: Placebo Group

Adult patients who have been in the Mayo Clinic Florida ICU for one week with moderate or severe depression will receive intravenous (IV) placebo

Drug: Placebo

Intravenous 0.9% saline infusions for three consecutive days.

Outcome Measures

Primary Outcome Measures

Change in depressive symptoms [Baseline, 7 days after third infusion]
Evaluated by Patient Health Questionnaire-9 (PHQ-9) used to assess degree of depression severity rating symptoms on a scale of 0=not at all, 3=nearly everyday. Higher score indicates greater depression severity.
Clinically significant improvement of depressive symptoms [24 hours after initial infusion]
Number of subjects to show clinically significant improvement in depressive symptoms, defined as a reduction in the PHQ-9 of 5 points or more.
Clinically significant improvement of depressive symptoms [24 hours after third infusion]
Number of subjects to show clinically significant improvement in depressive symptoms, defined as a reduction in the PHQ-9 of 5 points or more.
Clinically significant improvement of depressive symptoms [14 days after third infusion]
Number of subjects to show clinically significant improvement in depressive symptoms, defined as a reduction in the PHQ-9 of 5 points or more.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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 >

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Devang Sanghavi, MBBS, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Devang K. Sanghavi, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05803551

Other Study ID Numbers:

22-004767

First Posted:

Apr 7, 2023

Last Update Posted:

Apr 7, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Depression

Ketamine

Study Results

No Results Posted as of Apr 7, 2023