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NMDA Receptor Antagonist

Ketamine for Depression

Phase 4
Recruiting
Led By Laurel Morris
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 1
Awards & highlights

Study Summary

This trial aims to study the impact of a specific part of the brain called the subgenual anterior cingulate cortex (sgACC) on feelings of reduced pleasure (anhedonia) and anxiety

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.Check my eligibility
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.See study design
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 below
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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.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
sgACC response to the Incentive Flanker Task
Secondary outcome measures
Treatment-related change in sgACC response to the Incentive Flanker Task

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
~1090

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
861 Previous Clinical Trials
525,156 Total Patients Enrolled
35 Trials studying Depression
4,369 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,579 Total Patients Enrolled
667 Trials studying Depression
251,584 Patients Enrolled for Depression
Laurel MorrisPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the uppermost limit for participant enrollment in this research endeavor?

"Indeed, the information provided on clinicaltrials.gov indicates that this active clinical trial is actively seeking eligible candidates. The initial posting of the trial took place on January 1st, 2024, and it was most recently updated on January 9th, 2024. In total, the study aims to recruit 120 participants from a single research site."

Answered by AI

Is the recruitment phase for this medical study currently ongoing?

"Indeed, clinicaltrials.gov information indicates that this trial is actively seeking candidates. The original posting date of the study was on January 1st, 2024, and it was most recently updated on January 9th, 2024. A total of 120 participants will be admitted across one location."

Answered by AI

What is the level of safety associated with administration of ketamine to individuals?

"This Phase 4 trial, indicating the treatment's approval status, led our team at Power to assess Ketamine's safety as a score of 3."

Answered by AI

Can participants who are less than 30 years of age be considered for inclusion in this research project?

"Prospective participants must be within the age range of 18 to 65 years in order to meet the inclusion criteria for this clinical trial. It is worth noting that there are a total of 112 studies specifically designed for individuals under the age of 18, and another 607 studies targeting those over the age of 65."

Answered by AI

Who else is applying?

What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have medication resistant depression and I have already tried every antidepressant, tns, etc.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Neural Circuit Effects of Ketamine in Depression
James Murrough 2024. "Neural Circuit Effects of Ketamine in Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06213324.
~80 spots leftby Mar 2028
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