A Phase II Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effects of Ketamine Infusions in Clinically Depressed ICU Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Mayo Clinic
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Change in depressive symptoms
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- 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 >
- •Heart rate: < 50 or > 120, or Respiratory Rate: < 10 or >
- •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.
Arms & Interventions
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
Intervention: Placebo (Drug)
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
Intervention: Ketamine Hydrochloride (Drug)
Outcomes
Primary Outcomes
Change in depressive symptoms
Time Frame: 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
Time Frame: 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.
Clinically significant improvement of depressive symptoms
Time Frame: 24 hours after initial 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.
Clinically significant improvement of depressive symptoms
Time Frame: 24 hours 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Devang Sanghavi
Principal Investigator
Mayo Clinic