Depression
Conditions
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).
Interventions
DRUGKetamine 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
DRUGPlacebo
Intravenous 0.9% saline infusions for three consecutive days.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDevang Sanghavi, MBBS, MD
Mayo Clinic
Outcome results
None listed