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

Primary Purpose

Depression

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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. 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.

Sites / Locations

  • Mayo Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamine Group

Placebo Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in depressive symptoms
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
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
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
Number of subjects to show clinically significant improvement in depressive symptoms, defined as a reduction in the PHQ-9 of 5 points or more.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2023
Last Updated
June 26, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05803551
Brief Title
A Study of Ketamine Infusions to Treat Clinically-depressed ICU Patients
Official Title
A Phase II Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effects of Ketamine Infusions in Clinically Depressed ICU Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine Group
Arm Type
Experimental
Arm Description
Adult patients who have been in the Mayo Clinic Florida ICU for one week with moderate or severe depression will receive intravenous (IV) ketamine
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Adult patients who have been in the Mayo Clinic Florida ICU for one week with moderate or severe depression will receive intravenous (IV) placebo
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Other Intervention Name(s)
Ketalar
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous 0.9% saline infusions for three consecutive days.
Primary Outcome Measure Information:
Title
Change in depressive symptoms
Description
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.
Time Frame
Baseline, 7 days after third infusion
Title
Clinically significant improvement of depressive symptoms
Description
Number of subjects to show clinically significant improvement in depressive symptoms, defined as a reduction in the PHQ-9 of 5 points or more.
Time Frame
24 hours after initial infusion
Title
Clinically significant improvement of depressive symptoms
Description
Number of subjects to show clinically significant improvement in depressive symptoms, defined as a reduction in the PHQ-9 of 5 points or more.
Time Frame
24 hours after third infusion
Title
Clinically significant improvement of depressive symptoms
Description
Number of subjects to show clinically significant improvement in depressive symptoms, defined as a reduction in the PHQ-9 of 5 points or more.
Time Frame
14 days after third infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devang Sanghavi, MBBS, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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