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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 7 days after third infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 7 days after third infusion
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 • NCT031565041%
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
3,339 Previous Clinical Trials
3,062,095 Total Patients Enrolled
40 Trials studying Depression
3,535 Patients Enrolled for Depression
Devang Sanghavi, MBBS, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have experienced changes in my thinking or awareness.I am willing to participate and can provide informed consent.I am a woman of childbearing age and refuse to take a pregnancy test.I have a mass or abnormal blood vessel in my brain.I am currently taking medication that affects the NMDA receptor system.I have had issues with high pressure in my brain or eyes.My doctor thinks I might need to be restrained for safety.My weight is either over 115 kg or under 45 kg.I have been diagnosed with a serious heart, lung, liver, or kidney condition, or I am undergoing major surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine Group
- Group 2: Placebo Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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