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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-07

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ketamine for Older Adults Pilot

NCT04504175

Treatment Resistant Depression Refractory Depression Therapy-Resistant Depression +2 more

COMPLETED PHASE4

Intravenous Ketamine Plus Neurocognitive Training for Depression

NCT03237286

Depression

COMPLETED PHASE1/PHASE2

Effect of Ketamine in Depressive Symptoms of Elderly Patients With Visual Impairment.

NCT03473431

Depression in Old Age Ketamine

COMPLETED NA

MRI Studies of Emotion in Depression

NCT02429011

Major Depressive Disorder

COMPLETED

Antidepressant Effects of Nitrous Oxide

NCT05357040

Major Depressive Disorder Treatment Resistant Depression

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Ketamine Hydrochloride

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravenous 0.9% saline infusions for three consecutive days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Placebo

Intravenous 0.9% saline infusions for three consecutive days.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ketalar

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No