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Can a Low-Dose ketamine infusion lift depression in the ICU?

NCT ID NCT05803551

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This phase II trial tests whether three low-dose ketamine infusions, given over consecutive days, can reduce depressive symptoms in patients who have been in the intensive care unit (ICU) for at least a week and show signs of clinical depression. Participants receive either ketamine or a saline placebo, and their mood is tracked using a standard depression questionnaire. The goal is to see if ketamine can provide a safe, rapid way to ease the emotional burden of critical illness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketamine hydrochloride given as low-dose intravenous infusions
What this could lead to
If effective, ketamine infusions could offer a rapid way to ease depressive symptoms in critically ill ICU patients, improving their recovery experience.
What could go wrong
This is a small, early-phase trial, so results may not apply broadly. Ketamine can cause side effects like dissociation or blood pressure changes, and the benefit over placebo is unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

1 person

The number who actually took part.

Started

Jul 2025

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.