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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
Awards & highlights
Study Summary
This trial studies if ketamine infusions can help people with depression in ICU units.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
~910
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,033 Total Patients Enrolled
39 Trials studying Depression
3,505 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What prerequisites must an individual fulfill in order to join the trial?
"This clinical trial is seeking to recruit 50 participants, aged 18-99 with a diagnosis of depression."
Answered by AI
Does this trial embrace participants older than 35 years?
"This particular medical trial requires that patients are between 18 and 99 years of age. In comparison, there are 176 trials for minors and 870 trials for seniors."
Answered by AI
To what degree can Ketamine Group be risky for people receiving treatment?
"Given that this is a Stage 2 clinical trial, our team at Power put Ketamine Group's safety rating as a score of 2 since there exists evidence for its security but not yet any proof in favour of efficacy."
Answered by AI
Are recruitments into the trial still ongoing?
"Clinicaltrials.gov provides evidence that this research is not currently enrolling participants, as the last update was made on March 26th 2023. Although there are no vacancies for this particular trial at present, 1167 other trials have open positions available to interested patients."
Answered by AI
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