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NMDA Receptor Antagonist

Ketamine for Depression

Phase 2
Waitlist Available
Led By Devang Sanghavi, MBBS, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 7 days after third infusion

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Ketamine may cause side effects such as changes in blood pressure and heart rate, disorientation or confusion shortly after infusion, nausea or vomiting. It might also lead to vivid dreams or hallucinations during treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 7 days after third infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 7 days after third infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in depressive symptoms
Clinically significant improvement of depressive symptoms

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504
1%
Lightheadedness with low blood pressure
1%
Pump Malfunction
1%
PTSD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ketamine GroupExperimental Treatment1 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 GroupPlacebo Group1 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
2018
Completed Phase 4
~1890

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,326 Previous Clinical Trials
3,059,432 Total Patients Enrolled
Devang Sanghavi, MBBS, MDPrincipal InvestigatorMayo Clinic

Media Library

Ketamine Hydrochloride (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05803551 — Phase 2
Schizophrenia Research Study Groups: Ketamine Group, Placebo Group
Schizophrenia Clinical Trial 2023: Ketamine Hydrochloride Highlights & Side Effects. Trial Name: NCT05803551 — Phase 2
Ketamine Hydrochloride (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05803551 — Phase 2
~33 spots leftby Dec 2025
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