Anxiety & Depression Association of America

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

Purpose

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

Depression

Eligibility

Eligible Ages: Between 18 Years and 99 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Mayo Clinic

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.