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NMDA Receptor Antagonist
Ketamine for Depression
Phase 4
Recruiting
Led By James Murrough, MD/PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
MDD Group: Meets diagnostic criteria for current MDD according to the DSM-5
MDD Group: Male or female aged 18-65 years
Must not have
MDD Group: Clinically significant abnormalities of laboratories, physical examination, or ECG
MDD Group: Women who plan to become pregnant, are pregnant or are breast-feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 1
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial is testing how ketamine affects a specific brain area in people with depression who struggle with feeling pleasure and anxiety. Ketamine is known for its quick antidepressant effects. The study will look at changes in brain activity and symptoms over time. Ketamine's rapid and powerful antidepressant effects were discovered by chance and have led to significant research into its mechanisms.
Who is the study for?
This trial is for individuals with depression, specifically those who experience a lack of pleasure (anhedonia) or anxiety. Participants must meet certain criteria to join, but these specifics are not provided in the given information.
What is being tested?
The study is testing the effects of Ketamine compared to a placebo on brain function and symptoms of depression. It focuses on how Ketamine affects a part of the brain called the subgenual anterior cingulate cortex.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with Ketamine may include confusion, hallucinations, changes in blood pressure, nausea, and dizziness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with major depressive disorder according to DSM-5.
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I am between 18 and 65 years old.
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I am either not able to have children or I am using a reliable method of birth control.
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I can understand and agree to the study's details.
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I can understand and agree to the study's details.
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I am between 18 and 65 years old.
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I am a woman who can have children and have tested negative for pregnancy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have significant health issues found in lab tests, physical exams, or heart rhythm tests.
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I am a woman planning to become pregnant, am currently pregnant, or am breastfeeding.
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I do not have any unstable illnesses affecting my organs or immune system.
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I have significant health issues found in lab tests or physical exams.
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I do not have any unstable illnesses affecting my organs or immune system.
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I am currently diagnosed with major depression that includes psychotic features.
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My current mental health condition is considered severe.
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I am currently breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
sgACC response to the Incentive Flanker Task
Secondary study objectives
Treatment-related change in sgACC response to the Incentive Flanker Task
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: KetamineExperimental Treatment1 Intervention
Participants in the ketamine arm will receive a single infusion of ketamine
Group II: PlaceboPlacebo Group1 Intervention
Participants in the placebo arm will receive a single placebo infusion of normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1120
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
914 Previous Clinical Trials
570,759 Total Patients Enrolled
39 Trials studying Depression
6,062 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,751,521 Total Patients Enrolled
707 Trials studying Depression
261,058 Patients Enrolled for Depression
James Murrough, MD/PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Laurel MorrisPrincipal InvestigatorIcahn School of Medicine at Mount Sinai