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

NCT05803551 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 22-004767
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Ketamine Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Ketamine Hydrochloride DRUG

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

Also known as: Ketalar

Ketamine Group

Placebo DRUG

Intravenous 0.9% saline infusions for three consecutive days.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Depression

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Devang Sanghavi, MBBS, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: July 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)