Ketamine for Depression

Overseen by Devang Sanghavi, MBBS, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is studying the effects of giving ketamine through a vein to ICU patients with depression. These patients are chosen because they might not respond to usual treatments. Ketamine helps by changing brain chemicals to improve mood quickly. Ketamine has been investigated as a potential antidepressant option for treatment-resistant depression, showing rapid and robust effects.

Research Team

Devang Sanghavi, MBBS, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for Mayo Clinic Florida ICU patients with depression (PHQ-9 score ≥10) and specific conditions like heart attack, renal failure, COPD. Excluded are those with vital sign instability, ketamine allergy, intracranial issues, psychosis history, extreme weights, substance abuse withdrawal or recent use of hallucinogens including cannabis.

Inclusion Criteria

Has been in the Mayo Clinic Florida ICU for the past 1 week

PHQ-9 score of 10 or higher

I have been diagnosed with a serious heart, lung, liver, or kidney condition, or I am undergoing major surgery.

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

I have experienced changes in my thinking or awareness.

Treatment Details

Interventions

• Ketamine Hydrochloride (NMDA Receptor Antagonist)
• Placebo (Other)

Trial Overview The study tests if Ketamine Hydrochloride infusions can help ICU patients with depression compared to a placebo. Patients will be randomly assigned to receive either the real drug or a placebo without knowing which one they're getting.

Participant Groups

Group I: Ketamine Group Experimental Treatment 1 Intervention

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 II: Placebo Group Placebo Group 1 Intervention

Adult patients who have been in the Mayo Clinic Florida ICU for one week with moderate or severe depression will receive intravenous (IV) placebo

Ketamine Hydrochloride is already approved in Canada for the following indications:

Approved in Canada as Ketamine Hydrochloride for:

• Anesthesia
• Pain management
• Depression

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+