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

Phase 2

Not yet recruiting

• Conditions: Depression
• Interventions: Drug: Ketamine Hydrochloride; Drug: Placebo

• Registration Number: NCT05803551
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-03-26
• Study First Posted: 2023-04-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Study Start: 2025-03
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine Group	Ketamine Hydrochloride	Adult patients who have been in the Mayo Clinic Florida ICU for one week with moderate or severe depression will receive intravenous (IV) ketamine
Placebo Group	Placebo	Adult patients who have been in the Mayo Clinic Florida ICU for one week with moderate or severe depression will receive intravenous (IV) placebo

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States