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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05803551
• Other study ID #: 22-004767
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression

Intervention

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
• Placebo
Intravenous 0.9% saline infusions for three consecutive days.

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 7 days after third infusion
Primary	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.	24 hours after initial infusion
Primary	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.	24 hours after third infusion
Primary	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.	14 days after third infusion